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

10101–10125 of 89670

HighFDA (Devices)·Z-0244-2025·2024-11-06
Surgical patties and strips recalled for elevated endotoxin levels in raw materials
Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.
Product
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0026-2025·2024-11-06
Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits
Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0238-2025·2024-11-06
Surgical patties recalled due to higher-than-expected endotoxin levels
Integra LifeSciences Corp. is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may have resulted in out-of-specification finished products used during surgery.
Product
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0259-2025·2024-11-06
Pregnancy Test Kits Recalled for False Negative Results
Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.
Product
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0282-2025·2024-11-06
Smith & Nephew Knee Prosthesis Component Recalled for Incorrect Labeling
Smith & Nephew recalled a knee prosthesis component after a complaint indicated the package contained the wrong size and type of implant instead of what was labeled. This product substitution could result in incorrect implant during surgery.
Product
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0263-2025·2024-11-06
Westmed Flex Extenders recalled for connector failure risk
Westmed is recalling Flex Extenders because connectors may fail to hold properly, potentially causing the breathing circuit to leak or disconnect and creating life-threatening conditions. Over 50,000 units are affected across multiple U.S. states.
Product
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight conne
Category
Medical Device
Distribution
30 states
HighFDA (Food)·F-0078-2025·2024-11-06
Bistro 28 Chicken Enchilada Kits Recalled for Listeria Contamination
Reser's Fine Foods is recalling Bistro 28 Creamy Green Chile Chicken Enchilada Meal Kits due to Listeria monocytogenes contamination in the cooked chicken. The affected meal kits were distributed across 30 U.S. states.
Product
Item 407118, UPC 13454 38493, Bistro 28 Creamy Green Chile Chicken Enchilada Express Meal Kit. Make 6 Enchiladas. Ready in 5 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384937, Case UPC 13454 38493, Bistro 28 Creamy Gre
Category
Food
Distribution
30 states
HighFDA (Food)·F-0090-2025·2024-11-06
Green Chile Chicken Enchilada Kit Recalled Due to Listeria Contamination
Reser's Fine Foods is recalling Green Chile Chicken Enchilada Kits due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 30 U.S. states.
Product
Item 404977, UPC 13454 38191, Green Chile Chicken Enchilada Kit O.P. No Trays 2/6.75 LB. Distributed by Fresh Creative Foods, Vista, CA.
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0029-2025·2024-11-06
OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration
BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.
Product
CHLORPHENIRAMINE MALEATE 4MG — CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
Category
Drug
Distribution
2 states
HighFDA (Devices)·Z-0268-2025·2024-11-06
Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.
Product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0140-2025·2024-11-06
GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure
GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.
Product
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0275-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication
King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.
Product
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0093-2025·2024-11-06
Home Chef Chicken Street Taco Kits Recalled for Listeria Contamination
Reser's Fine Foods is recalling Home Chef Chicken Street Taco Kits due to Listeria monocytogenes contamination in the cooked chicken. The kits were distributed across 32 states with use-by dates from September through November 2024.
Product
Item 406581, UPC 40134 30435, Home Chef Kit Street Taco Chicken With Tray, 2/4.985 LB. Distributed by Fresh Creative Foods, Vista, CA or by Reser's Fine Foods Inc. Beaverton, OR. Item 406581, UPC 40134 30435, Home Chef Chicken Street Taco Kit With Trays, 2/4.985 LB. Distributed
Category
Food
Distribution
30 states
HighFDA (Food)·F-0079-2025·2024-11-06
Reser's Chicken Quesadilla Meal Kit Recalled for Listeria Contamination
Reser's Fine Foods is recalling Bistro 28 Chicken Quesadilla Express Meal Kits distributed across 30 states due to potential Listeria monocytogenes contamination in the cooked chicken.
Product
Item 407121, UPC 13454 38496, Bistro 28 Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384968, Case UPC 13454 38496, Bistro 28 Chicken Quesadilla Expres
Category
Food
Distribution
30 states
HighFDA (Food)·F-0081-2025·2024-11-06
Chicken Meal Kits Recalled for Listeria Contamination
Reser's Fine Foods recalled Bistro 28 Chicken Street Tacos Express Meal Kits due to Listeria monocytogenes in the cooked chicken. The recall affects 2,880 cases distributed across 31 states.
Product
Item 407120, UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Meal Kit. Made 6 Tacos. Ready in 3 MIN. Net wt. 22 oz (1 LB 6 OZ) 624g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384951, Case UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Mea
Category
Food
Distribution
30 states
HighFDA (Drugs)·D-0027-2025·2024-11-06
Cinacalcet tablets recalled for nitroso impurity above FDA limits
Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0096-2025·2024-11-06
Sprouts Chicken Street Tacos recalled due to Listeria contamination
Sprouts Farmers Market is recalling Sprouts Chicken Street Tacos due to Listeria monocytogenes contamination. Approximately 8,206 units with sell-by dates from September 2 to November 7, 2024, were distributed across 17 states.
Product
Sprouts Chicken Street Taco, 6 taco, perishable item kept under refrigeration, packaged in a plastic tray with plastic lid, Net wt of 1.5lbs, UPC 205916813991. Sell by dates of 9/2/2024 to 11/7/2024.
Category
Food
Distribution
17 states
HighFDA (Devices)·Z-0265-2025·2024-11-06
Thyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution
Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.
Product
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Ac
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0071-2025·2024-11-06
Glaser Organic Farms Salsa Recalled for Possible Glass Contamination
Glaser Organic Farms recalls All Raw Vegan Certified Organic Salsa due to potential glass contamination. The product may pose a risk of injury to consumers.
Product
All Raw Vegan Certified Organic Salsa, Glaser Organic Farms, Handmade fresh from our farm to you,Net wt. 8 oz, Plastic PET Container with cover, Keep Refrigerated, UPC 832910 001514
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0262-2025·2024-11-06
Dural Graft Implants Recalled for Out-of-Specification Endotoxin Levels
Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant (Model 80-1477US, Lot CT007694) due to endotoxin levels exceeding specifications. No adverse events have been reported.
Product
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0234-2025·2024-11-06
Abbott STI and HPV Test Kits Recalled for Quality Control Failures
Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.
Product
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0095-2025·2024-11-06
HMS Hatch Chicken Enchilada Kits recalled for Listeria contamination
Meal kits containing cooked chicken have been recalled due to Listeria monocytogenes contamination. The affected product was distributed across 30 U.S. states.
Product
Item 404866, UPC 13454 38152, HMS Hatch Chicken Enchilada Kit 1/22.225 LB. Distributed by Fresh Creative Foods, Vista, CA.
Category
Food
Distribution
30 states
HighFDA (Food)·F-0091-2025·2024-11-06
Asian Style Chicken Stir Fry Kit recalled for Listeria monocytogenes
Reser's Fine Foods recalled Asian Style Chicken Stir Fry Kits distributed by Fresh Creative Foods due to Listeria monocytogenes contamination in the cooked chicken. 192 cases were distributed across 30 US states.
Product
Item 406740, UPC 13454 38316, Asian Style Chicken Stir Fry Kit On Premise With Trays 2/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0278-2025·2024-11-06
Knee Prosthesis Implant Recall: Wrong Size Component Shipped
Smith & Nephew is recalling a knee prosthesis component because packages were found to contain the wrong size implant. The size 3 left component was shipped instead of the size 4 left as labeled.
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0028-2025·2024-11-06
Prescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity
Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide

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10101–10125 of 89670