Updated 11 hours ago · U.S. FDA & CPSC

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Every new U.S. recall of food, medicines, medical devices and household products, in one place, updated every day. Search for a product or brand you own.

Counts are for the last 30 days.

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Latest recalls

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: N…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 6510

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0048-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software Ver…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 2244

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0034-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par…

Alere San Diego, Inc. · San Diego, CA, United States

Why: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Product details, where it was sold and what to do

Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;

Quantity: 13,256,075

Distribution: Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.

Recall number Z-3273-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable …

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 970

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0054-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Vers…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 33102

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0031-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software Ve…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 5738

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0030-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Positron Emission Tomography and Computed Tomography System, Model: uMI 780

Shanghai United Imaging Healthcare Co., Ltd. · Shanghai, China

Why: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Product details, where it was sold and what to do

Positron Emission Tomography and Computed Tomography System, Model: uMI 780

Quantity: 1

Distribution: US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.

Recall number Z-3288-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable …

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 4480

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0058-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software V…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 1899

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0024-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: N…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 4850

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0047-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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Medical devices · Oct 7, 2026 · Class II · Ongoing

Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;

Philips North America · Cambridge, MA, United States

Why: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.

Product details, where it was sold and what to do

Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;

Quantity: 30

Distribution: Worldwide distribution - Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Equator. Guinea, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Monaco, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, …

Recall number Z-3317-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable …

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 5440

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0066-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version: …

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 20760

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0042-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Version…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 25350

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0008-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Vers…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 6319

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0032-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C

Percussionaire Corporation · Sandpoint, ID, United States

Why: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation

Product details, where it was sold and what to do

Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual

Quantity: 229,105

Distribution: Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.

Recall number Z-3321-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Descr…

American Nitrile Operations Llc · Grove City, OH, United States

Why: Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.

Product details, where it was sold and what to do

Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove

Quantity: 17,481,000

Distribution: US Nationwide distribution.

Recall number Z-3291-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Atellica CH Revised C-Reactive Protein (RCRP)

Siemens Healthcare Diagnostics, Inc. · Tarrytown, NY, United States

Why: The potential for falsely elevated results.

Product details, where it was sold and what to do

Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;

Quantity: 42940 units (3938 US, 39002 OUS)

Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, …

Recall number Z-3335-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class III · Ongoing

HeartSine samaritan PAD (Public Access Defibrillator)

HeartSine Technologies Ltd · Belfast, United Kingdom

Why: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Product details, where it was sold and what to do

HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069

Quantity: 31,834

Distribution: U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Recall number Z-3270-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Vers…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 7650

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0011-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software

Shanghai United Imaging Healthcare Co., Ltd. · Shanghai, China

Why: Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.

Product details, where it was sold and what to do

Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software

Quantity: 34

Distribution: US Nationwide distribution in the states of CA, PR, UT, WV, ND, NE, NC, TX, ID, LA, MT, FL, CO, IN, KY, AL, OH, MI, IA, MO, NY, NV, TN, WV, SC, WI, IL, MS, MA, NJ.

Recall number Z-3283-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable P…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 40

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0061-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cem…

Heraeus Medical GmbH (Dental Division) · Wehrheim, Germany

Why: Potential for monomer liquid leakage.

Product details, where it was sold and what to do

PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).

Quantity: 59,660 units

Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

Recall number Z-3302-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cemen…

Heraeus Medical GmbH (Dental Division) · Wehrheim, Germany

Why: Potential for monomer liquid leakage.

Product details, where it was sold and what to do

PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.

Recall number Z-3304-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No

American Contract Systems Inc · Tiffin, OH, United States

Why: Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associa…

Product details, where it was sold and what to do

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO

Quantity: 1,804 kits total

Distribution: US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.

Recall number Z-3292-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 S…

Tandem Diabetes Care, Inc. · San Diego, CA, United States

Why: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps …

Product details, where it was sold and what to do

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No

Quantity: 177

Distribution: US Nationwide distribution.

Recall number Z-3330-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Vers…

ASP Global, LLC. · Austell, GA, United States

Why: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Product details, where it was sold and what to do

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Quantity: 4610

Distribution: US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Recall number Z-0010-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC

Cardinal Health 200, LLC · Waukegan, IL, United States

Why: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Product details, where it was sold and what to do

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA

Quantity: 3677 kits

Distribution: US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.

Recall number Z-3295-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fish…

Alere San Diego, Inc. · San Diego, CA, United States

Why: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Product details, where it was sold and what to do

McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002; Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215; Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23; Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;

Quantity: 50,265,835

Distribution: Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden.

Recall number Z-3271-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Oct 7, 2026 · Class II · Ongoing

Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual

Percussionaire Corporation · Sandpoint, ID, United States

Why: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation

Product details, where it was sold and what to do

Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual

Quantity: 228,596

Distribution: Worldwide - US Nationwide distribution including in the states of CA, PA, OK, GA, TX, OH, WI, WA, NY, MO, FL, DE, LA, SC, WV, NJ, NE, KS, NC, AL, CO, VA, OR, AZ, IL, CT, ID, NH, UT, TN, MD, VT, MS, NV, DC, ME, IA, AR, HI, ND, IN, MT, NM, MN, MI, SD, MA, AK, RI and the countries of Canada, Belgium, Chile, France, Germany, Israel, Italy, Latvia, Netherlands, Norway, Oman, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Kuwait, Australia, South Africa.

Recall number Z-3324-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

What to do if you own a recalled product

  1. Match it exactly. Recalls usually cover specific lot or batch numbers, "best by" dates, model numbers or sizes. Compare every detail on your product with the notice.
  2. Stop using it. For food and medicine, do not eat, take or give it to pets, even if it looks and smells fine: Listeria and Salmonella do not change how food looks.
  3. Follow the remedy. Most recalls offer a refund, repair or replacement. Return food to the store or follow the company's instructions; for products, contact the company named in the notice.
  4. Do not stop a prescription medicine on your own. Ask your pharmacist or doctor first. They can swap you to an unaffected batch.
  5. Report problems. In the U.S., report illnesses from food or medicine to FDA MedWatch and injuries from products to SaferProducts.gov.

Beware of recall scams

Criminals send fake "recall refund" texts and emails that ask you to pay a "shipping fee" or enter card details. Real recalls never ask for payment. Paste any suspicious recall message into our scam text checker. Read more: Product recalls: how they work and what to do.

Sources: U.S. Food and Drug Administration Enforcement Reports (via openFDA) and the U.S. Consumer Product Safety Commission recall database. FDA enforcement reports list recalls when they are classified, which can be a few weeks after the company's first announcement. Vehicle recalls are available per vehicle in our VIN check.