The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10576–10600 of 88183

  • HighFDA (Devices)·Z-0274-2025·2024-11-06

    FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance

    King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.

    Product
    KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0092-2025·2024-11-06

    Reser's Asian Style Stir Fry Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling 420 cases of Asian Style Stir Fry meal kits containing potentially contaminated cooked chicken due to Listeria monocytogenes. Affected products were distributed across 30 states with Use By dates from September through November 2024.

    Product
    Item 406897,UPC 13454 38407, Asian Style Stir Fry Single Serve OP no Trays 1/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • 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 (Devices)·Z-0235-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.

    Product
    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Contamination

    Integra LifeSciences recalls 33,478 units of surgical patties and strips due to higher-than-expected endotoxin levels in raw materials that may have contaminated finished products.

    Product
    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. 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
    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 (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 (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.…
    Category
    Food
    Distribution
    30 states
  • 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-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 (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 (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-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 (Food)·F-0087-2025·2024-11-06

    Premium Street Taco Kit Meal Recalled for Listeria Monocytogenes

    Reser's Fine Foods is recalling Premium Street Taco Kits due to Listeria monocytogenes contamination in the cooked chicken. Approximately 4,100 cases were distributed across 30 states.

    Product
    Item 404700, UPC 13454 38075, Premium Street Taco Kit With Trays, 2/4.9875 lbs. Distributed by Fresh Creative Foods Vista, CA.
    Category
    Food
    Distribution
    30 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 (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-0082-2025·2024-11-06

    Don Pancho Enchilada Meal Kit Recalled for Listeria Contamination

    Reser's Fine Foods recalls Don Pancho Creamy Green Chile Chicken Enchilada Express Meal Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 4,179 cases distributed across 30 states.

    Product
    Item 404856, UPC 71117 12506, Don Pancho Creamy Green Chile Chicken Enchilada Express Meal Kit. Made 6 Enchiladas . Ready in 4 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. There are 6 packages per case. Distributed by Reser's Fine Foods Inc. Beaverton, OR. www.DONPANCHO.COM.
    Category
    Food
    Distribution
    30 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…
    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 (Devices)·Z-0242-2025·2024-11-06

    Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels

    Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.

    Product
    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. 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-0243-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.

    Product
    SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. 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-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 (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-0237-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.

    Product
    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. 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