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.

13001–13025 of 27206

  • HighFDA (Devices)·Z-0971-2024·2024-02-07

    Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation

    Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.

    Product
    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0945-2024·2024-02-07

    Philips Achieva MRI Scanner Recall: Loose Coil Seals May Cause Skin Injury

    Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.

    Product
    Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2024·2024-02-07

    Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects

    AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.

    Product
    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2024·2024-02-07

    Knee Replacement Implant Component Recalled Due to Material Oxidation Risk

    The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0802-2024·2024-02-07

    Milk N Cookies Keto Brick recalled for undeclared MCT oil and acacia fiber

    Savage Sports LLC is recalling Milk N Cookies Keto Brick due to undeclared MCT oil and acacia fiber in the formulation. Approximately 7,461 units distributed via the company's website are affected.

    Product
    Milk N Cookies Keto Brick / 1 Brick, 145g 5.1 oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0287-2024·2024-02-07

    Hydrogen Peroxide Oral Rinse Recalled for Manufacturing Deviations

    Den-Mat Holdings recalls Hydrogen Peroxide Oral Rinse products nationwide due to manufacturing deviations that may result in products not conforming to labeled specifications.

    Product
    Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2024·2024-02-07

    TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation

    MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.

    Product
    TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0837-2024·2024-02-07

    FDA Recalls Terragene Bionova PCD Device Due to Instructions Discrepancy

    Terragene S.A. is recalling Terragene Bionova PCD (Model PCD222-C) medical devices nationwide due to a discrepancy between FDA-cleared instructions for use and the actual instructions distributed with the products.

    Product
    Terragene Bionova PCD (PCD222-C)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0803-2024·2024-02-07

    Solgar Glucosamine Chondroitin Recalled Due to Wrong Product Packaging Error

    Nestle Health Science recalled Solgar Glucosamine Chondroitin (120-tablet bottles) distributed in six states due to a packaging error where Megasorb B-Complex was filled into mislabeled bottles.

    Product
    Solgar, Triple Strength, Shellfish -Free, Glucosamine Chondroitin MSM, 120 Tablets per bottle. Glass Bottle, 12 per Case, Store at room temperature . Product Number -1319
    Category
    Drug
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0964-2024·2024-02-07

    Blood Culture Bottle Kit Recalled for Expired Component Documentation Issue

    Medline is recalling blood culture bottle kits with mismatched component expiration date documentation, creating risk of using expired components if not verified by users.

    Product
    MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0966-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Undocumented Component Expiration

    Medline is recalling blood culture collection kits because the Bactec component expiration date is not documented on the kit insert. Users who do not check the component directly risk using an expired element.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0866-2024·2024-02-07

    Surgical needle holders distributed with incorrect product labels

    Aesculap Inc is recalling 53 JACOBSON DUROGRIP TC micro needle holders that were shipped with incorrect product labels, which may cause delays during surgical procedures.

    Product
    MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2024·2024-02-07

    Medline Blood Culture Kits recalled for inaccurate expiration dating

    Medline recalls Blood Culture Kits because kit inserts fail to reflect the expiration date of included Bactec components. Users could unknowingly use expired components if they don't independently check the Bactec label.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0969-2024·2024-02-07

    Medline Blood Culture Tray Adult recalled for incomplete component labeling

    Medline recalls Adult Blood Culture Trays due to incomplete documentation of Bactec component expiration dates on kit inserts. Users should verify the component expiration date before use.

    Product
    MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0775-2024·2024-01-31

    Tapee Tea packets recalled for undeclared pharmaceutical contamination

    Tapee Tea packaged in paper packets is being recalled because samples contain undeclared pharmaceutical substances (dexamethasone and piroxicam). The contamination poses serious health risks from unintended medication exposure.

    Product
    Tapee Tea packaged in paper packets - 5 packets per bag
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0781-2024·2024-01-31

    Publix Custom Made Pizzas Recalled Due to Listeria Contamination in Lettuce

    Publix Custom Made Pizzas distributed in eight states are being recalled because the shredded lettuce ingredient may contain Listeria monocytogenes.

    Product
    Publix Custom Made Pizzas, variable weights and sizes, packed in cardboard box, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-0782-2024·2024-01-31

    Publix Custom Burrito Bowls Recalled Due to Listeria Contamination Risk

    Publix Super Markets is recalling Custom Burrito Bowls due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. The bowls were distributed in Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia during December 5-14, 2023.

    Product
    Publix Custom Burrito Bowls, variable weights and sizes, packed in plastic containers, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0316-2024·2024-01-31

    Robitussin Honey CF Max Non-Drowsy Adult recalled for microbial contamination

    GSK Consumer Healthcare recalls Robitussin Honey CF Max Non-Drowsy Adult due to microbial contamination in non-sterile products distributed nationwide. Affected lot numbers carry specific expiration dates.

    Product
    Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0784-2024·2024-01-31

    Publix Custom Made Platters Recalled Due to Potential Listeria Contamination

    Publix is recalling custom made platters distributed across eight states due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient. Consumers should not eat platters prepared between December 5-14, 2023.

    Product
    Publix Custom Made Platters, variable weights and sizes, packed in plastic containers, intended for immediate consumption (https://www.publix.com/mc/order-ahead/order-deli-platters?nav=header).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0788-2024·2024-01-31

    Lara's Bakery 3 LLC Recalls Pan de Racho Bread for Undeclared Allergens

    Lara's Bakery 3 LLC recalls Pan de Racho (Feria) bread distributed in Iowa and Wisconsin for undeclared allergens including sesame, with potential presence of coconut, soy, wheat, milk, and eggs.

    Product
    Pan de Racho (Feria), Net Wt. 2lbs, individually packaged in clear plastic bag.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0785-2024·2024-01-31

    Publix Self-Service Salad Recalled for Potential Listeria Contamination

    Publix is recalling self-service salad from its salad bar distributed December 5-14, 2023, in eight states due to potential Listeria monocytogenes contamination in shredded lettuce supplied by Fresh Express.

    Product
    Publix Self Service Salad from the Salad Bar, variable weights and sizes, packed in plastic containers, intended for immediate consumption.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0261-2024·2024-01-31

    Drug recall: Bleomycin injection vials recalled due to glass contamination

    Pfizer is recalling 3,546 vials of Bleomycin for Injection due to the presence of glass particulate matter. The affected lot was distributed nationwide in the USA, Netherlands, and Libya.

    Product
    BLEOMYCIN — BLEOMYCIN (BLEOMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0777-2024·2024-01-31

    Outrageous Oat Cookies Recalled for Undeclared Wheat Allergen

    Wegmans Food Markets is recalling Outrageous Oat Cookies due to undeclared wheat. The product poses a serious health risk to consumers with wheat allergies or celiac disease.

    Product
    Outrageous Oat Cookies packaged in 5pk and also sold in Bulk
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0780-2024·2024-01-31

    Publix Sub Sandwiches Recalled for Potential Listeria Contamination

    Publix Custom Made Sub Sandwiches are being recalled due to potential Listeria monocytogenes contamination in the shredded lettuce ingredient supplied by Fresh Express. Products were distributed between December 5-14, 2023 in southeastern states.

    Product
    Publix Custom Made Sub Sandwiches, variable weights and sizes, individually wrapped in paper, intended for immediate consumption (https://www.publix.com/menu-subs-and-wraps?merch=hp_viz_nav_subs_wraps).
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0789-2024·2024-01-31

    Pan Surtido Bakery Products Recalled for Undeclared Allergens

    Lara's Bakery 3 LLC is recalling Pan Surtido multi-pack bakery trays distributed in Iowa and Wisconsin through November 2023 due to undeclared allergens including sesame, coconut, soy, and milk, with potential for wheat and eggs.

    Product
    Pan Surtido with label reading: Panaderia Lara's Bakery, 701 N 3rd Ave Suite C Marshalltown IA 50158. Multi-pack tray containing Concha, Cema, Polvoron, Tostado de Guatemala, Pan de Guatemala, Canasta, Garibaldi, Marianas, Muffin, Pan Fino, Pastel Glass, Pan de Trigo, Puerco, Bol
    Category
    Food
    Distribution
    0 states