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

10626–10650 of 31360

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 (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-0248-2025·2024-11-06
Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin
Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.
Product
SURG STRP 1/8X6 Model/Catalog Number: 801449. 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
HighNHTSA·23V441000·2024-11-06
Volvo Trucks Recall for Loose Steering Gear Fasteners
Volvo Trucks is recalling 2023-2024 VN, VHD, and VAH trucks because steering gear fasteners may not be properly tightened, risking loss of vehicle control. Dealers will tighten the fasteners at no cost to owners.
Product
VOLVO — 2023 VOLVO VN
Category
Vehicle
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-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-0277-2025·2024-11-06
Smith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.
Product
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Category
Medical Device
Distribution
0 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 (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 (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 (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 (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 (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-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 (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 (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 (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-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 (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 (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-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-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-0270-2025·2024-11-06
Laryngeal Tube Device Recalled for Unapproved Pediatric Indication
King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.
Product
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
Category
Medical Device
Distribution
Distributed nationwide
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

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10626–10650 of 31360