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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 · Sep 23, 2026 · Class II · Ongoing

Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;

Mirion Technologies (Capintec), Inc. · Florham Park, NJ, United States

Why: Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground.

Product details, where it was sold and what to do

Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;

Quantity: 783

Distribution: Worldwide distribution - US Nationwide and the countries of ALGERIA, AUSTRIA, BANGLADESH, BRASIL, Brazil, CANADA, CHILE, Costa Rica, Ecuador, France, Hanoi Vietnam, Hong Kong, INDIA, ISRAEL, ITALY, Malaysia, Philippines, POLAND, Saudi Arabia, SOUTH KOREA, Spain, SWEDEN, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIATES, UNITED KINGDOM, VIETNAM.

Recall number Z-3193-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

REF:B5ST Ethicon Endo-Surgery, Inc

Stryker Sustainability Solutions · Tempe, AZ, United States

Why: Reusable access port system may crack or seperate during use.

Product details, where it was sold and what to do

REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

Quantity: 9072 UNITS

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3187-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm …

F & A Foundation · Tulsa, OK, United States

Why: Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

Product details, where it was sold and what to do

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x 18mm/152-31818; 20mm x 20mm/152-32020; 9mm x 7mm/152-40907; 11mm x 10mm/152-41110; 15mm x 12mm/152-41512; 18mm x 18mm/152-41818; 20mm x 20mm/152-42020

Quantity: 600

Distribution: US Nationwide distribution in the states of TX, OK, MD, VT, MA, LA.

Recall number Z-3211-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufa…

Howmedica Osteonics Corp. · Mahwah, NJ, United States

Why: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Product details, where it was sold and what to do

SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3206-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A

Quantity: 12 kits

Distribution: US Nationwide distribution.

Recall number Z-3121-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Philips PIC iX Essentials REF:867093

Philips North America · Cambridge, MA, United States

Why: Due to software malfunction, patient information system may freeze and become unresponsive.

Product details, where it was sold and what to do

Philips PIC iX Essentials REF:867093

Quantity: 312 units

Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe …

Recall number Z-3142-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

IV Sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Product details, where it was sold and what to do

IV Sets with drip chambers

Quantity: 6,105,468

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3161-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Plum administration sets

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Product details, where it was sold and what to do

Plum administration sets

Quantity: 163,500,199

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3156-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

StatStrip Glucose Hospital Meter System

Nova Biomedical Corporation · Waltham, MA, United States

Why: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this def…

Product details, where it was sold and what to do

StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.

Quantity: 20,616 units

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Recall number Z-3128-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

StatStrip Glucose and B- Ketone meter

Nova Biomedical Corporation · Waltham, MA, United States

Why: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this def…

Product details, where it was sold and what to do

StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.

Quantity: 1,858 units

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Recall number Z-3130-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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Medical devices · Sep 23, 2026 · Class I · Ongoing

Haylard UNIV IMAGING BIOPSY TRUCUSTOM

AVID Medical, Inc. · Toano, VA, United States

Why: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Product details, where it was sold and what to do

Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

Quantity: 340 kits

Distribution: Domestic: IL, NC, VA, WY;

Recall number Z-3154-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes

Abiomed, Inc. · Danvers, MA, United States

Why: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Product details, where it was sold and what to do

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

Quantity: 5232 units (3733 US, 1499 OUS) 36 3

Distribution: Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Israel, India, Italy, Japan, Kuwait, Luxembourg, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Pakistan, Poland, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Taiwan;

Recall number Z-3148-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

GE Healthcare · Chicago, IL, United States

Why: Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.

Product details, where it was sold and what to do

Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions

Quantity: 116 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3169-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110

Happiest Baby, Inc · Los Angeles, CA, United States

Why: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Product details, where it was sold and what to do

Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110

Quantity: 1055 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin…

Recall number Z-3175-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

IV Sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Product details, where it was sold and what to do

IV Sets with drip chambers

Quantity: 100,712,657

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3160-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembol…

Product details, where it was sold and what to do

Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Quantity: 135 units

Distribution: US Nationwide distribution in the state of CA.

Recall number Z-3137-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Oncology sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Product details, where it was sold and what to do

Oncology sets with drip chambers

Quantity: 107,800

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3158-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

Datex-Ohmeda, Inc. · Madison, WI, United States

Why: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this i…

Product details, where it was sold and what to do

Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

Quantity: 140 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3190-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Oncology sets with drip chambers

ICU Medical, Inc. · San Clemente, CA, United States

Why: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

Product details, where it was sold and what to do

Oncology sets with drip chambers

Quantity: 28,550

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3159-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

StatStrip Glucose and B- Ketone meter

Nova Biomedical Corporation · Waltham, MA, United States

Why: A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this def…

Product details, where it was sold and what to do

StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.

Quantity: 8,939 units

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Recall number Z-3131-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number …

GE Medical Systems Information Technologies Inc · Waukesha, WI, United States

Why: Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.

Product details, where it was sold and what to do

Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV

Quantity: 29,570 (23,632 US; 5,938 OUS)

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3143-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A

Quantity: 2718 kits

Distribution: US Nationwide distribution.

Recall number Z-3125-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class I · Ongoing

Haylard 18G SINGLE SHOT EPI TRAY

AVID Medical, Inc. · Toano, VA, United States

Why: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Product details, where it was sold and what to do

Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;

Quantity: 1640 kits

Distribution: Domestic: IL, NC, VA, WY;

Recall number Z-3151-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field repla…

Datex-Ohmeda, Inc. · Madison, WI, United States

Why: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this i…

Product details, where it was sold and what to do

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665

Quantity: 410 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3192-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

Datex-Ohmeda, Inc. · Madison, WI, United States

Why: Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this i…

Product details, where it was sold and what to do

Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

Quantity: 7 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3191-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 23, 2026 · Class II · Ongoing

REF:2B5ST Ethicon Endo-Surgery, Inc

Stryker Sustainability Solutions · Tempe, AZ, United States

Why: Reusable access port system may crack or seperate during use.

Product details, where it was sold and what to do

REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM

Quantity: 2838 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3183-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 23, 2026 · Class II · Ongoing

Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray

Pfizer · Manhattan, NY, United States

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.

Quantity: N/A

Distribution: US Nationwide.

Recall number D-0853-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 23, 2026 · Class II · Ongoing

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle

Inventia Healthcare Limited · Kalyan, N/A, India

Why: Failed Dissolution Specifications

Product details, where it was sold and what to do

Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

Quantity: 13567 bottles

Distribution: U.S. Nationwide

Recall number D-0852-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 23, 2026 · Class II · Ongoing

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar

SUN PHARMA /TARO · Hawthorne, NY, United States

Why: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Product details, where it was sold and what to do

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5

Quantity: 65,328 50g jars

Distribution: Nationwide in the USA

Recall number D-0848-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Sep 23, 2026 · Class II · Ongoing

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only

Safecor Health, LLC · Woburn, MA, United States

Why: Failed Stability Specifications

Product details, where it was sold and what to do

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

Quantity: N/A

Distribution: Nationwide in the USA.

Recall number D-0841-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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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.