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

10601–10625 of 31360

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 (Food)·F-0080-2025·2024-11-06
Bistro 28 Chicken Burrito Bowl Express Meal Kit recalled for Listeria
Reser's Fine Foods is recalling Bistro 28 Chicken Burrito Bowl Express Meal Kits distributed across 31 states due to Listeria monocytogenes contamination in the cooked chicken. No illnesses have been reported.
Product
Item 407119, UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. Ready in 5 MIN. Net wt. 25 oz (1 LB 9 OZ) 788g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384944, Case UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. 4/25oz.
Category
Food
Distribution
30 states
HighFDA (Devices)·Z-0247-2025·2024-11-06
Surgical patties and strips recalled for elevated endotoxin levels
Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.
Product
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. 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-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 (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-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-0273-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use
King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.
Product
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0094-2025·2024-11-06
Home Chef Asian Style Chicken Stir Fry Kits Recalled for Listeria Contamination
Reser's Fine Foods is recalling Home Chef Asian Style Chicken Stir Fry meal kits due to potential Listeria monocytogenes contamination in the cooked chicken. The affected products were distributed across 30 states.
Product
Item 406873, UPC 40134 30852, Home Chef Asian Style Chicken Stir Fry OP With Trays 2/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
Category
Food
Distribution
30 states
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-0280-2025·2024-11-06
Surgical Screwdriver Battery Pack Recalled for Foreign Material Contamination
Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device sterility.
Product
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
Category
Medical Device
Distribution
1 state
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 (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 (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-0261-2025·2024-11-06
Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk
Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.
Product
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
Category
Medical Device
Distribution
Distributed nationwide
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-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-0245-2025·2024-11-06
Codman Surgical Patties and Strips recalled for elevated endotoxin levels
Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.
Product
SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. 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-0030-2025·2024-11-06
Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination
Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
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-0279-2025·2024-11-06
Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings
The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.
Product
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0255-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher Endotoxin Levels
Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.
Product
SURG STRP 3X6 Model/Catalog Number: 801456. 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-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
0 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 (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
HighNHTSA·23V439000·2024-11-06
2023 Lincoln Nautilus Brake System Risk from Defective Rear Shock Absorbers
Ford is recalling 366 2023 Lincoln Nautilus vehicles due to incorrectly manufactured rear shock absorbers that may damage the brake hose, potentially extending stopping distance and increasing crash risk. Dealers will inspect and replace affected components at no cost.
Product
LINCOLN — 2023 LINCOLN NAUTILUS
Category
Vehicle
Distribution
Distributed nationwide

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10601–10625 of 31360