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

10126–10150 of 89670

HighFDA (Devices)·Z-0236-2025·2024-11-06
Codman Surgical Patties Recalled for Endotoxin Contamination
Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.
Product
SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. 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 (Food)·F-0085-2025·2024-11-06
Reser's Chicken Street Taco Kit Recalled for Listeria Contamination
Reser's Fine Foods is recalling Chicken Street Taco Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The product was distributed across 32 states.
Product
Item 404710, UPC 13454 38080, Chicken Street Taco Kit with Trays, 4.985 lb. Item 13454 38080 Chicken Street Taco Kit with Trays, 2/4.985 lb. bags per case. Distributed by Fresh Creative Foods, Vista, CA or Reser's Fine Foods, Inc. Beaverton, OR.
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0251-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.
Product
SURG STRP 3/4X6 Model/Catalog Number: 801452. 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-0257-2025·2024-11-06
Covidien Chameleon PTA Balloon Catheter Recalled for Failed Pressure Testing
Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.
Product
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US),
Category
Medical Device
Distribution
Distributed nationwide
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 (Drugs)·D-0032-2025·2024-11-06
Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits
Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
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 (Devices)·Z-0231-2025·2024-11-06
ClariTEE Probe Ultrasound Recall Due to Defective Epoxy Sealing
ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.
Product
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0267-2025·2024-11-06
Nihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Category
Medical Device
Distribution
29 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 (Devices)·Z-0254-2025·2024-11-06
Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.
Product
SURG STRP 2X6 Model/Catalog Number: 801455. 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-0031-2025·2024-11-06
Cinacalcet Tablets Recalled Due to Nitrosamine Impurity
Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0086-2025·2024-11-06
Reser's Don Pancho Meal Kits Recalled for Listeria Contamination
Reser's Fine Foods recalled 16,696 cases of Don Pancho Kit OP Street Taco Chicken meal kits due to Listeria monocytogenes contamination in the cooked chicken. The kits were distributed across 30 US states.
Product
Item 404711, UPC 13454 38082, Don Pancho Kit OP Street Taco Chicken NO Trays, 4.985 lb. Case GTIN 10013454380823, Case UPC Code 1345438082, Don Pancho Kit OP Street Taco Chicken NO Trays. 2/4.985 lb. bags per case. Distributed by Fresh Creative Foods, Vista, CA or Reser's Fine
Category
Food
Distribution
30 states
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 (Food)·F-0072-2025·2024-11-06
New Horizen BBQ Chicken Sandwich Recalled for Listeria Contamination
Whitsons Food Service recalls 1,152 units of New Horizen Gourmet BBQ Pulled Chicken Sandwiches distributed in New York due to potential Listeria monocytogenes contamination.
Product
New Horizen Gourmet BBQ Pulled Chicken Sandwich on Everything Bialy; KEEP FROZEN; COOK & SERVE; Cooking Instructions: Conventional oven (Preheat oven to 350oF). Thaw product overnight. Cook meal for 20 mins or until an internal temp of 165oF. For quality purposes only, cook produ
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0264-2025·2024-11-06
Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error
Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.
Product
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
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 (Food)·F-0084-2025·2024-11-06
Don Pancho Chicken Street Tacos Meal Kit Recalled for Listeria
Reser's Fine Foods is recalling Don Pancho Chicken Street Tacos Meal Kit due to Listeria monocytogenes contamination in the cooked chicken. Approximately 7,909 cases were distributed across 30 states.
Product
Item 404764, UPC 71117 12500, Don Pancho Chicken Street Tacos Express Meal Kit. Made 6 Tacos. Ready in 3 MIN. Net wt. 22 oz (1 LB 6 OZ) 624g. Case GTIN 10071117125006, Case UPC 71117 12500, Don Pancho Chicken Street Tacos Express Meal Kit. Made 6 Tacos 6/22oz. bags. Distributed
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0229-2025·2024-11-06
Olympus Endoscopic Flushing Pump Recalled Due to Function Loss
Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.
Product
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2025·2024-11-06
Surgical Patties and Strips recalled for endotoxin contamination in raw materials
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.
Product
SURG STRP 3-1/2X6 Model/Catalog Number:801457. 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-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-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 (Devices)·Z-0241-2025·2024-11-06
Surgical Patties and Strips Recalled for Elevated Endotoxin Levels
Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.
Product
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. 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-0269-2025·2024-11-06
AMBU King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Indication
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.
Product
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
Category
Medical Device
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

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10126–10150 of 89670