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.

8526–8550 of 26961

  • HighFDA (Devices)·Z-0419-2025·2024-11-20

    Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments

    AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.

    Product
    Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2025·2024-11-20

    Medical Convenience Kits Recalled for Detachable Metal Flakes in Surgical Instruments

    AVID Medical is recalling Halyard Shoulder Pack medical convenience kits because the sponge forceps and towel clamps contain loose metal flakes that could detach and enter a patient's surgical site during use, potentially causing foreign body reactions.

    Product
    Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2025·2024-11-20

    IMAGEnet 6 Ophthalmic Data System Hood Report Display Issue

    IMAGEnet 6 ophthalmic software's Hood Report overlay can mislead clinicians about clinical correlations unsupported by evidence. Affects 3,144 units nationwide.

    Product
    The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2025·2024-11-20

    IV Fluid Container Leak During Filling — SECURE 500 mL EVA Container Recall

    The Metrix Company is recalling SECURE 500 mL EVA containers (REF 66050) used for intravenous administration because a limited number have been found to leak during filling. Affected lots were distributed nationwide and to Canada.

    Product
    SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; 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-0342-2025·2024-11-20

    IV Fluid Bags Recalled Due to Leaking During Filling

    The FDA is recalling Imed EVA BAG IV bags after a limited number were found to leak during filling. The affected bags were distributed nationwide and in Canada.

    Product
    Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; 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-0458-2025·2024-11-20

    MEERA CL operating table stops responding during surgery when IR-Hand Control errors occur

    The MEERA CL surgical operating table may fail to respond when error code 50037 occurs on its IR-Hand Control, causing the table to stop moving during procedures and 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: 720001F0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0437-2025·2024-11-20

    Surgical Sponge Forceps and Towel Clamps Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard CATH LAB PACK surgical kits because sponge forceps and towel clamp components may shed loose metal flakes that could enter a patient's surgical site, posing a risk of local or foreign body reactions.

    Product
    Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2025·2024-11-20

    Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes

    AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.

    Product
    Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2025·2024-11-20

    Halyard Pacemaker Drape Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.

    Product
    Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0124-2025·2024-11-20

    Westby Cheese Curds Recalled Due to Potential E. coli Contamination

    Westby Cooperative Creamery is recalling Westby Cheese Curds due to potential generic E. coli contamination. Affected products have a sell-by or expiration date of November 26, 2024.

    Product
    Westby Cheese Curds, UPC 7 50388-30105 2. Keep Refrigerated. No Added Preservatives. Manufactured by Westby Cooperative Creamery, Westby, WI 54667. White, Yellow, and Mixed Curds are packaged in 12 oz. (340g) bags or in 10 lb. bulk boxes.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0440-2025·2024-11-20

    Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes

    AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2025·2024-11-20

    SafeControl Bed Handset May Move Unexpectedly After Power Restoration

    The SafeControl handset component of Sentida beds may revert to an active mode after power restoration, potentially causing unintended bed movement. Consumers should ensure beds are safely positioned before power interruptions.

    Product
    SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2025·2024-11-20

    Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness

    Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.

    Product
    Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2025·2024-11-20

    IV Fluid Bags Found to Leak During Filling; Manufacturer Recalls Affected Units

    The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.

    Product
    SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; 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-0333-2025·2024-11-20

    IV Bag Containers Recalled Due to Leaking During Filling

    The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.

    Product
    CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; 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-0399-2025·2024-11-20

    Surgical instrument kits recalled for potential loose metal flake hazard

    Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.

    Product
    Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06
    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
  • HighFDA (Devices)·Z-0351-2025·2024-11-20

    Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage

    Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.

    Product
    Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0359-2025·2024-11-20

    Medline urine collection kits recalled for non-sterile specimen containers

    Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.

    Product
    URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2025·2024-11-20

    Halyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.

    Product
    Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2025·2024-11-20

    Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk

    AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.

    Product
    Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0389-2025·2024-11-20

    Surgical Instruments Recalled for Loose Metal Flakes in Set-Up Packs

    AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and foreign body reactions.

    Product
    Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2025·2024-11-20

    Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes

    Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
    Category
    Medical Device
    Distribution
    Distributed nationwide