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.

21976–22000 of 88183

  • ModerateFDA (Devices)·Z-0129-2023·2022-11-02

    ConvaTec Active Life Stoma Pouch Recalled for Release Liner Malfunction

    ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.

    Product
    ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileostomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2023·2022-11-02

    LumiraDx SARS-CoV-2 Quality Control Kit: Incorrect Lot Numbers

    LumiraDx is recalling 83 SARS-CoV-2 Antigen Liquid Quality Control Kits (batch 2002204017) with incorrect vial lot numbers. The kits contain Flu A/B lot numbers instead of SARS-CoV-2 Ag numbers, causing error messages and preventing device use.

    Product
    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2023·2022-11-02

    EMPOWER 3D Knee Tibial Insert Recall Due to Packaging Mix-Up

    Hip and knee implant boxes from Encore Medical may contain the wrong product, potentially causing surgery delays. The FDA is recalling affected units to prevent unavailability of correct implants.

    Product
    EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0132-2023·2022-11-02

    Vortex MP Port Titanium Recalled for Missing Printed Instructions

    Angiodynamics is recalling 11 Vortex MP Port Titanium implantable ports because printed Instructions for Use were not shipped with the devices. Missing instructions could lead to improper implantation or post-operative care.

    Product
    Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filters Recalled Due to Device Splitting Risk

    TELEFLEX is recalling 355 units of Iso-Gard Filter S medical gas filters nationwide due to incidents of device splitting or detaching during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2023·2022-10-26

    Medical Gas Filter Devices Recalled Due to Splitting and Detachment Risk

    Teleflex is recalling Iso-Gard Filter S microbial medical gas filters that may split or detach during use. The recall affects 164 units distributed nationwide.

    Product
    Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0076-2023·2022-10-26

    Medical gas filter recalled due to splitting and detachment risk

    TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.

    Product
    Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0038-2023·2022-10-26

    Dark Chocolate Almonds recalled for undeclared milk allergen

    Dark Chocolate Almonds sold at Safeway, Albertsons, and Roths Fresh Market contain undeclared milk allergen. The FDA Class I recall affects 1,701 cases distributed in Oregon and Washington.

    Product
    Dark Chocolate Almonds distributed to Safeway/Albertsons is packaged in a clear clamshell container with a top label that displays PRODUCE Dark Chocolate Almonds , net weight of 9.5 oz., UPC 0 19061 19371 2. Distributed by Rivertrail Foods with an address of 4660 Ridge Dr. NE.…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0077-2023·2022-10-26

    Teleflex Catheter Mount and Filter May Split or Detach During Use

    Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.

    Product
    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0072-2023·2022-10-26

    Iso-Gard Filter S Recalled for Device Splitting or Detachment During Use

    Teleflex is recalling Iso-Gard Filter S microbial filters (60,500 units) due to incidents of device splitting or detaching during use. The filters protect patients and equipment from bacterial and viral contamination in breathing systems.

    Product
    Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0073-2023·2022-10-26

    Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment

    TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.

    Product
    Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0080-2023·2022-10-26

    Fenugreek dietary supplement recalled for potential Salmonella contamination

    Best Nutritionals LLC is recalling Best Naturals Fenugreek 610mg capsules due to potential Salmonella contamination. The product was distributed online via internet sellers and FBA.

    Product
    White plastic bottle with green, gold, and blue labeling containing 360, 610mg hard gelatin capsules of Fenugreek seed powder, labeled in part, "Best Naturals Fenugreek Premium Herbal 610mg 3rd Party Lab Tested 360 CAPSULES DIETARY SUPPLEMENT", best by 10/24, lot 102120
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0094-2023·2022-10-26

    N Antiserum to Human IgG Fails High-Dose Hook Effect Performance Standards

    Siemens N Antiserum to Human IgG reagent batches are not meeting performance standards for high-dose immunoassay testing. The issue affects 10,201 packs distributed nationwide and may result in inaccurate diagnostic test results.

    Product
    N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0044-2023·2022-10-26

    Cheese Straws Recalled for Undeclared Wheat and Milk Allergens

    Flathau's Fine Foods is recalling Cheese Straws Delta Bred products due to undeclared wheat and milk allergens. 433 units were distributed across 12 states. Consumers with allergies should stop consuming and discard affected products.

    Product
    Flathau's Fine Foods Cheese Straws Delta Bred Cheese Straws packaged in 4oz and 6oz cartons 12 packages per case
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0106-2023·2022-10-26

    Chest Tube Insertion Tray Recalled Due to Over-Sterilization of Suture Component

    Medline recalls CENTURION SnagFree Chest Tube insertion trays because a silk suture component was sterilized twice instead of once, potentially compromising its integrity. The affected lot contains 18 kits distributed in California and Texas.

    Product
    CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2023·2022-10-26

    Abbott MitraClip and TriClip Clip Delivery Systems: Locking Malfunction Risk

    Abbott is recalling MitraClip and TriClip Clip Delivery Systems due to clip locking malfunctions. Failed procedures may result in mitral regurgitation recurrence, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2023·2022-10-26

    MitraClip Clip Delivery System Recalled for Locking Malfunctions

    Abbott Vascular is recalling MitraClip Clip Delivery System devices due to observed increases in clip locking malfunctions that can lead to recurrence of mitral regurgitation, device embolization, or tissue injury.

    Product
    Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2023·2022-10-26

    Surgical Implant Kit Recall: Incorrect Drill Guide Included

    Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage during surgery.

    Product
    SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0063-2023·2022-10-26

    Lyons Ready Care Thickened Orange Juice recalled for spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Orange Juice 46 fl oz cartons due to indication of product spoilage. Specific lot numbers distributed nationwide are affected.

    Product
    Lyons Ready Care Thickened Orange Juice packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Food)·F-0054-2023·2022-10-26

    Lyons Ready Care Thickened Apple Honey Nectar Recalled Due to Spoilage

    Lyons Magnus LLC is recalling Lyons Ready Care Thickened Apple Honey Nectar due to indications of product spoilage. The nationwide recall affects 645 cases with specific lot numbers and best-by dates in March 2023.

    Product
    Lyons Ready Care Thickened Apple Honey Nectar packaged in combi-bloc multi wall paper cartons 46 fl oz cartons - 6 cartons to a case
    Category
    Food
    Distribution
    48 states
  • HighFDA (Devices)·Z-0100-2023·2022-10-26

    Synthes SPEED implant recall: drill guide size mismatch in surgical kit

    Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.

    Product
    SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2023·2022-10-26

    Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.

    Product
    Medicina Reusable Oral syringe 1ml Code: OTH01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0113-2023·2022-10-26

    Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.

    Product
    Medicina Reusable Oral syringe 5ml Code: OTH05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0049-2023·2022-10-26

    Karlsburger Kitchens beef gravy mix recalled for undeclared gluten

    Karlsburger Kitchens beef gravy mix is recalled for containing undeclared gluten despite its gluten-free label. The product poses a risk to consumers with celiac disease or gluten sensitivity.

    Product
    Karlsburger Kitchens NSLP 140 Beef Gravy Mix, Gluten Free. Packaged in the following sizes: 1. Item 32312. Net Weight 12 oz (340 gm) 2. Item 32325. Net Weight 25 lb. (11.34 kg). Manufactured in a plant that handles Gluten. Karlsburger Foods, Inc Monticello, MN 55362.
    Category
    Food
    Distribution
    4 states