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.

8776–8800 of 27089

  • 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 (Devices)·Z-0266-2025·2024-11-06

    Medical Diagnostic Stain Product Recalled for Out-of-Specification Color Change

    Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange after discovery that the solution can change color during use, resulting in out-of-specification fluorescent staining results.

    Product
    remel BactiDrop Acridine Orange, REF 21502, 50 per package.
    Category
    Medical Device
    Distribution
    8 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 (Food)·F-0083-2025·2024-11-06

    Don Pancho Chicken Quesadilla Meal Kits Recalled for Listeria Monocytogenes

    Reser's Fine Foods is recalling Don Pancho Chicken Quesadilla Express Meal Kits due to potential Listeria monocytogenes contamination in the cooked chicken component. No illnesses have been reported.

    Product
    Item 404852, UPC 71117 12507, Don Pancho Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Case GTIN 10071117125075, Case UPC 7111712507, Don Pancho Chicken Quesadilla Express Meal Kit. 6/22.5oz bags. Distributed by Re
    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
  • 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-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-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 (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 (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 (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 (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 (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-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-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-0253-2025·2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.

    Product
    SURG STRP 1-1/2X6 Model/Catalog Number: 801454. 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-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 (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 (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 (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
    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 (Devices)·Z-0239-2025·2024-11-06

    Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin

    Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.

    Product
    SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. 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-0228-2025·2024-11-06

    Hospital Bed Fails to Send Remote Alerts Through Nurse Call System

    Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.

    Product
    a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B10
    Category
    Medical Device
    Distribution
    Distributed nationwide