Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

15876–15900 of 31567

HighFDA (Devices)·Z-0671-2024·2024-01-17
SPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.
Product
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0694-2024·2024-01-17
SoClean 3 CPAP Cleaner Recalled Over Ozone Exposure Risk
SoClean, Inc is voluntarily recalling 40,075 units of the SoClean 3 sleep equipment cleaner due to potential ozone gas exposure. The manufacturer is providing an updated user manual with safety instructions and a protective hose and mask adapter.
Product
SoClean 3, REF SC1400, Automated Supplemental Sleep Equipment Maintenance System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0654-2024·2024-01-17
Abiomed Introducer Kits recalled due to sterile barrier compromise
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
Product
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0663-2024·2024-01-17
Baxter Flo-Thru Intraluminal Shunt recalled for marketing brochure inaccuracy
Baxter Healthcare is recalling marketing materials for the Flo-Thru Intraluminal Shunt due to inaccurate content that does not match the product's official instructions for use or prescribing information.
Product
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0657-2024·2024-01-17
Baxter Coseal Premix Surgical Sealant: Marketing Brochure Information Inaccuracy
Baxter Healthcare Corporation is recalling Coseal Premix Surgical Sealant due to inaccurate information in a marketing brochure that conflicts with the product's Instructions for Use and Prescribing Information.
Product
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0661-2024·2024-01-17
Marketing brochure for Baxter Floseal hemostatic device contains inaccurate content
Baxter Healthcare is recalling a cardiovascular surgery marketing brochure for Baxter Floseal Hemostatic Matrix Fast Prep because it contains inaccurate content that does not match the official product instructions and prescribing information.
Product
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0664-2024·2024-01-17
Peri-Guard Repair Patch marketing brochure contains inaccurate information
Baxter Healthcare recalls a marketing brochure for Peri-Guard Repair Patch because it contains inaccurate information that does not match the product's Instructions for Use.
Product
Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0666-2024·2024-01-17
Cardiovascular Surgical Patch Marketing Brochure Contains Inaccurate Information
Baxter is recalling marketing materials for Vascu-Guard Peripheral Vascular Patch because a brochure contains inaccurate information that conflicts with the product's official instructions and prescribing information.
Product
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0659-2024·2024-01-17
Baxter Vascular Probe Marketed with Inaccurate Prescribing Information
Baxter Healthcare is recalling its Vascular Probe due to inaccurate marketing materials that do not align with the product's official Instructions for Use. Providers should reference only the official IFU and PI.
Product
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 74
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0710-2024·2024-01-17
SUPREX Carb & Sugar Block dietary supplement recalled for subpotent chromium content
Vita 360, LLC is recalling SUPREX Plant Based Nutrition Carb & Sugar Block supplements (Lot #2633) because FDA testing found chromium content at only 16% of the declared amount.
Product
Brand Name: SUPREX Plant Based Nutrition. Product Name: Carb & Sugar Block. Product Size: 120 Vegetable Cellulose Capsules per bottle. Container description: White Plastic Bottle 300CC with white cap sealed with clear plastic Total Package size: Master Case with 81 Bottles conta
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-0668-2024·2024-01-17
Baxter PERI-GUARD SUPPLE marketing brochure contains inaccurate instructions
Baxter Healthcare Corporation is recalling PERI-GUARD SUPPLE surgical devices because the marketing brochure contains inaccurate content that does not align with the products' actual Instructions for Use.
Product
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM U
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0656-2024·2024-01-17
Baxter Flo-Rester Vessel Occluder Recall Due to Inaccurate Marketing Brochure
Baxter Healthcare is recalling Flo-Rester internal vessel occluders because marketing materials contain inaccurate information that doesn't match the product's Instructions for Use and Prescribing Information.
Product
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0705-2024·2024-01-17
Shiloh Farms Bread for Life Organic 7 Grain Labeling Error Recall
Shiloh Farms recalled 534 cases of Bread for Life Organic 7 Grain due to labeling error: cholesterol and sodium daily values listed in grams instead of milligrams. Product content is accurate.
Product
Shiloh Farms Bread for Life Organic 7 Grain UPC 0-47593-02812-7
Category
Food
Distribution
29 states
ModerateFDA (Devices)·Z-0712-2024·2024-01-17
QMS Tacrolimus Calibrators Recalled for Quality Degradation from Improper Storage
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
Product
QMS Tacrolimus Calibrators, Product code 10015573
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0684-2024·2024-01-17
Model CYF-5 cystonephrofiberscope cleaning instructions updated by Olympus
Shirakawa Olympus has updated cleaning instructions for the Model CYF-5 cystonephrofiberscope, removing reusable cleaning brushes from the manual cleaning protocol while single-use brushes remain compatible.
Product
Model No. CYF-5, Cystonephrofiberscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0658-2024·2024-01-17
Medical Device Recall: Baxter Ostene Hemostasis Material Marketing Brochure Inaccuracy
Baxter Healthcare is recalling marketing materials for the Ostene Hemostasis Material due to inaccuracies that do not align with the product's official Instructions for Use and Prescribing Information.
Product
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0675-2024·2024-01-17
Cordis MYNXGRIP Vascular Closure Device Carton Labeling Error
Cordis recalled 70 units of MYNXGRIP vascular closure devices due to carton label errors affecting two lots. Carton boxes were labeled incorrectly, though individual device labels are correct.
Product
MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0685-2024·2024-01-17
Cystonephrofiberscope Model CYF-5R Cleaning Procedure Recall: Reusable Brushes Removed
Shirakawa Olympus Co., Ltd. is updating cleaning instructions for the Model CYF-5R Cystonephrofiberscope. Reusable cleaning brushes have been removed from manual cleaning procedures; single-use brushes remain approved.
Product
Model No. CYF-5R, Cystonephrofiberscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0692-2024·2024-01-17
Videoscope Cleaning Instructions Updated: Reusable Brushes No Longer Compatible
Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
Product
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0674-2024·2024-01-17
Cordis MYNXGRIP 5F Vascular Closure Device Carton Labeling Error
Cordis US Corp is recalling MYNXGRIP 5F vascular closure devices due to incorrect labeling on carton boxes. The carton labels between two lots were swapped; however, the individual device labels remain correct.
Product
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0687-2024·2024-01-17
Bronchovideoscope Manual Cleaning Updated: Reusable Brushes No Longer Approved
Olympus has updated cleaning instructions for the EVIS EXERA III Bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; only single-use brushes should be used.
Product
Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0690-2024·2024-01-17
Cysto-Nephro Videoscope Model CYF-VHR: Reusable Brush Cleaning Instructions Updated
Olympus updated cleaning instructions for the Model CYF-VHR Cysto-Nephro Videoscope. Reusable brushes have been removed from manual cleaning procedures; single-use brushes remain compatible.
Product
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0708-2024·2024-01-17
Robotic Drill Recall: Users Unable to Resolve Disconnection Errors
Blue Belt Technologies is recalling 1,859 CORI REAL INTELLIGENCE Robotic Drills (models ROB10013 and ROB10013S) because users cannot resolve drill disconnection error messages. No illnesses or injuries have been reported.
Product
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0665-2024·2024-01-17
Peri-Guard Repair Patch Recall Due to Inaccurate Marketing Brochure
Baxter Healthcare recalls Peri-Guard Repair Patch due to cardiovascular surgery marketing brochure containing inaccurate content that does not align with the product's Instructions for Use.
Product
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0686-2024·2024-01-17
FDA updates cleaning instructions for EVIS EXERA III bronchovideoscope
Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.
Product
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
Category
Medical Device
Distribution
Distributed nationwide

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15876–15900 of 31567