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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 30, 2026 · Class II · Ongoing

Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219

Quantity: 695 kits

Distribution: US Nationwide.

Recall number Z-3265-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);

Quantity: 965

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3243-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);

Quantity: 387

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3232-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T

Quantity: 486 kits

Distribution: US Nationwide.

Recall number Z-3267-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…

Baxter Healthcare Corporation · Deerfield, IL, United States

Why: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Product details, where it was sold and what to do

PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13

Quantity: 824 units

Distribution: Worldwide distribution - US Nationwide and the country of Canada.

Recall number Z-3263-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves …

Baxter Healthcare Corporation · Deerfield, IL, United States

Why: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Product details, where it was sold and what to do

PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08

Quantity: 169 units

Distribution: Worldwide distribution - US Nationwide and the country of Canada.

Recall number Z-3262-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, H…

Baxter Healthcare Corporation · Deerfield, IL, United States

Why: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

Product details, where it was sold and what to do

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No

Quantity: 2

Distribution: US Nationwide distribution in the states of Colorado and Florida.

Recall number Z-3257-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for us…

Becton, Dickinson and Company · Irvine, CA, United States

Why: Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

Product details, where it was sold and what to do

ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

Quantity: 15,455 cables

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

Recall number Z-3250-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Ingenia Ambition S and Ingenia Ambition X

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);

Quantity: 922

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3237-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Product details, where it was sold and what to do

HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve

Quantity: 21 units

Distribution: US Nationwide distribution in the states of FL, IA, OH, NE, TN.

Recall number Z-3221-2026 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 30, 2026 · Class II · Ongoing

Medline convenience kits containing Healthmark Instrument Channel Brushes

Medline Industries, LP · Northfield, IL, United States

Why: Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

Product details, where it was sold and what to do

Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.

Quantity: 90 kits (US)

Distribution: US Nationwide distribution in the states of MN and SD.

Recall number Z-3230-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova…

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);

Quantity: 82

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3240-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Halyard IV START KIT NON-STERILE

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

Why: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Product details, where it was sold and what to do

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01

Quantity: 192 kits (4 cases)

Distribution: US Nationwide distribution.

Recall number Z-3261-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I

Medline Industries, LP · Northfield, IL, United States

Why: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Product details, where it was sold and what to do

Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A; 6) NEURO PACK, Catalog Number: DYNJ86656; 7) NEURO ACD, Catalog Number: DYNJ904549G

Quantity: 234 kits

Distribution: US Nationwide.

Recall number Z-3268-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class I · Ongoing

INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set

CooperSurgical, Inc. · Trumbull, CT, United States

Why: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Product details, where it was sold and what to do

INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.

Quantity: 2,643 boxes (13,215 units)

Distribution: Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.

Recall number Z-3139-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

SEASPINE ORTHOPEDICS CORPORATION · Carlsbad, CA, United States

Why: The proximal thread depth of the spinal device is out of design specification.

Product details, where it was sold and what to do

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Quantity: 270 units

Distribution: US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.

Recall number Z-3226-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Philips Ultrasound, LLC · Bothell, WA, United States

Why: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

Product details, where it was sold and what to do

Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234

Quantity: 219 units

Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, CT, FL, GA, KS, MD, MN, NJ, NY, OH, PA, SC, TN, TX, VA, WA, WI and the countries of Austria, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lithuania, Netherlands, Norway, Philippines, Poland, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan , United Kingdom, Vietnam.

Recall number Z-3249-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), …

Midmark Corporation · Versailles, OH, United States

Why: A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Product details, where it was sold and what to do

Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724

Quantity: 33 units

Distribution: US Nationwide distribution.

Recall number Z-3220-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector

Olympus Corporation of the Americas · Center Valley, PA, United States

Why: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Product details, where it was sold and what to do

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

Quantity: 105 units

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Recall number Z-3245-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Ingenia 3.0T and Ingenia 3.0T CX

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

Quantity: 1447

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3238-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD

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

Why: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.

Product details, where it was sold and what to do

Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

Quantity: 9480 kits

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

Recall number Z-3255-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Maquet SAS · Orleans Cedex 2, France

Why: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Product details, where it was sold and what to do

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Quantity: 667

Distribution: US Nationwide distribution.

Recall number Z-3224-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Evolution upgrade 1.5T and Evolution upgrade 3.0T

Philips North America Llc · Cambridge, MA, United States

Why: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Product details, where it was sold and what to do

Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);

Quantity: 91

Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, I…

Recall number Z-3235-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

Ventec Life Systems, Inc. · Bothell, WA, United States

Why: Labeling; Oxygen Cylinders do not contain required medical gas labeling

Product details, where it was sold and what to do

REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Conserver

Quantity: 2 units

Distribution: US Nationwide distribution in the states of FL, IA, OH, NE, TN.

Recall number Z-3222-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

CooperVision, Inc. · West Henrietta, NY, United States

Why: A small number of lenses within the affected lot are of the incorrect power.

Product details, where it was sold and what to do

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

Quantity: 3060

Distribution: US Nationwide distribution in the states of MN, OH, WI.

Recall number Z-3248-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class I · Ongoing

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/…

Boston Scientific Corporation · Maple Grove, MN, United States

Why: Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Product details, where it was sold and what to do

Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5

Quantity: 262,686

Distribution: Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, …

Recall number Z-3214-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A

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

Why: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.

Product details, where it was sold and what to do

Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795

Quantity: 17503 kits

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

Recall number Z-3254-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector

Olympus Corporation of the Americas · Center Valley, PA, United States

Why: Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Product details, where it was sold and what to do

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

Quantity: 2,142 units

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.

Recall number Z-3246-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

Halyard IV START KIT NON-STERILE

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

Why: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Product details, where it was sold and what to do

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02

Quantity: 816 kits (17 cases)

Distribution: US Nationwide distribution.

Recall number Z-3260-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medical devices · Sep 30, 2026 · Class II · Ongoing

PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide…

Baxter Healthcare Corporation · Deerfield, IL, United States

Why: There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Product details, where it was sold and what to do

PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14

Quantity: 6 units

Distribution: Worldwide distribution - US Nationwide and the country of Canada.

Recall number Z-3264-2026 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.