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.

8676–8700 of 27089

  • HighFDA (Devices)·Z-0343-2025·2024-11-20

    Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.

    Product
    Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2025·2024-11-20

    Halyard C Section Pack surgical kits recalled for loose metal flakes

    AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.

    Product
    Halyard C SECTION PACK - Medical convenience kits Model Number: SJCS66-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0448-2025·2024-11-20

    Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments

    AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.

    Product
    Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0044-2025·2024-11-20

    Lanthanum Carbonate Chewable Tablets Recalled for Crushed and Broken Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets (1000mg) distributed nationwide due to complaints of crushed and broken tablets that fail manufacturing specifications.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0460-2025·2024-11-20

    FDA Recalls MEERA CL Mobile Operating Tables for Unintended Movement Stops

    Getinge Usa Sales Inc is recalling 112 MEERA CL mobile operating tables because error code 50037 may cause the table to stop moving unexpectedly when controlled via IR hand control, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0046-2025·2024-11-20

    Perio Maintenance Rinse Recalled for Subpotent Stannous Fluoride Concentration

    Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.

    Product
    Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0045-2025·2024-11-20

    Hydralazine Tablets Recalled Due to Failed Impurities and Degradation Testing

    Hydralazine HCl Tablets 25mg are recalled nationwide due to failed impurities and degradation specifications. The recall affects approximately 25,814 tablets distributed by Avet Pharmaceuticals and MAJOR Pharmaceuticals.

    Product
    Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0123-2025·2024-11-20

    Berkeley Springs Water Recalled for Coliform Contamination

    Berkeley Club Beverages is recalling Berkeley Springs Water Purified and Distilled due to coliform contamination detected during testing. The recall affects 1,304 bottles distributed in West Virginia, Maryland, and Virginia.

    Product
    Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,090426,090526,090626.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0043-2025·2024-11-20

    Lanthanum Carbonate 1000mg Chewable Tablets Recalled for Broken and Crushed Tablets

    Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg due to complaints of crushed and broken tablets. The recall affects 1,875 boxes distributed nationwide.

    Product
    Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0363-2025·2024-11-20

    Karl Storz Irrigation Tubing Recalled for Unapproved Label Use

    Karl Storz Endoscopy is recalling Irrigation Tubing for the Endomat Select UP210 because its label claims an intended use that the FDA has not approved for U.S. distribution.

    Product
    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0350-2025·2024-11-20

    Medline arthroscopy surgical kits recalled for incomplete packaging seal

    Medline Industries is recalling 80 arthroscopy surgical convenience kits due to incomplete packaging seals. The affected lot numbers are 24GBI464 and 24HBO800.

    Product
    ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0104-2025·2024-11-13

    Aunt Millie's Bakehouse Hot Dog Buns Recalled for Undeclared Sesame Allergen

    Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse Whole Grain White Hot Dog Buns for containing undeclared sesame. Approximately 10,987 cases distributed across multiple states.

    Product
    Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0105-2025·2024-11-13

    Gordon Food Service Hawaiian Rolls Recalled for Undeclared Sesame

    Perfection Bakeries is recalling Gordon Food Service Hawaiian Pull-Apart Dinner Rolls due to undeclared sesame. The recall affects 61,658 cases distributed across 12 states; consumers with sesame allergies should not consume the product.

    Product
    Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. Net. Wt. 9lbs. 6oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Food)·F-0100-2025·2024-11-13

    Bread Recall: Undeclared Sesame in Aunt Millie's Bakehouse White Pullman

    Perfection Bakeries recalls Aunt Millie's Bakehouse White Pullman Bread (22 oz) due to undeclared sesame. The recall affects 7,092 cases distributed across multiple states.

    Product
    Aunt Millie s Bakehouse White Pullman Bread 1/2" Sliced 22 OUNCE. 12 unlabeled 22 OUNCE LOAVES per sale unit case, product code 9518. Net Wt. 16lb 8oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0040-2025·2024-11-13

    Ascorbic Acid Injection Recalled Nationwide for Glass Contamination

    Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.

    Product
    Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0101-2025·2024-11-13

    Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Bakehouse

    Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse 100% Whole Wheat Pullman Bread due to undeclared sesame. Affected product was distributed across twelve U.S. states.

    Product
    Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0103-2025·2024-11-13

    Bakery Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Texas Toast

    Perfection Bakeries is recalling Aunt Millie's Bakehouse Texas Toast due to undeclared sesame, which poses a serious risk to consumers with sesame allergies. Approximately 1,500 cases were distributed across multiple states.

    Product
    Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lbs 8oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0099-2025·2024-11-13

    Aunt Millie's Bakehouse Hawaiian Hamburger Buns Recalled for Undeclared Sesame

    Aunt Millie's Bakehouse Hawaiian Hamburger Buns contain undeclared sesame and are being recalled by Perfection Bakeries LLC. The Class I recall affects 6,400 cases distributed across 12 states.

    Product
    Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0102-2025·2024-11-13

    Aunt Millie's Whole Grain Dinner Rolls Recalled for Undeclared Sesame

    Perfection Bakeries LLC is recalling 1,144 cases of Aunt Millie's Bakehouse Whole Grain Dinner Rolls due to undeclared sesame. The product was distributed in 12 states. Consumers with sesame allergies should not consume this product.

    Product
    Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0287-2025·2024-11-13

    Surgical neurological sponges recalled for detaching X-ray markers

    American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.

    Product
    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Drugs)·D-0035-2025·2024-11-13

    Timolol Maleate Eye Drops Recalled Due to Defective Container

    FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0285-2025·2024-11-13

    Endoscopic Vessel Harvesting System Recalled for Assembly Defect

    Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.

    Product
    Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0122-2025·2024-11-13

    Kirkland Signature Butter Recalled for Missing Milk Allergen Statement

    Kirkland Signature Salted Sweet Cream Butter is being recalled because the packaging may lack the required 'Contains Milk' allergen warning. Consumers with milk allergies who purchased this product in Texas should not consume it.

    Product
    Kirkland Signature Salted Sweet Cream Butter, Net Wt 16 oz (1 lb) 453g, Four 4 oz (113g) sticks UPC 96619-38488.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0106-2025·2024-11-13

    MyChai Chai Tea Concentrate Recalled for pH Control and Documentation Issues

    MyChai Chai Tea Concentrate Original is recalled nationwide. The FDA found pH levels above 4.1 and missing production records.

    Product
    MyChai Chai Tea Concentrate Original. Product is packaged in plastic (HDPE) 1/2gallon bottle, cap has a foil liner that is induction sealed during the bottling process. Shelf stable 3 year expiration from date of manufacture. Ingredients: Water, Sugar, Organic Black Tea, Organ
    Category
    Food
    Distribution
    Distributed nationwide