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.

8426–8450 of 26961

  • SevereFDA (Devices)·Z-0296-2025·2024-11-20

    Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure

    Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.

    Product
    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0138-2025·2024-11-20

    Processed Fajita Peppers Recalled for Potential E. coli O157:H7 Contamination

    ImperialFresh processed fajita peppers made by FreshPoint Denver, Incorporated have been recalled due to potential E. coli O157:H7 contamination. Seven cases distributed in Colorado are affected.

    Product
    154784 1 / 5LB IMPERIALFRESH PROC FAJITA GRN PEPRED PEP W All lot codes
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0137-2025·2024-11-20

    Yellow Onion Products Recalled for E. Coli O157:H7 Contamination

    IMPERIALFRESH processed yellow onions are being recalled due to potential E. coli O157:H7 contamination. Products were distributed in Colorado and produced October 8-22, 2024.

    Product
    Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147 4/5LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 1/4 All lot codes; 259369 1 / 5
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0298-2025·2024-11-20

    FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0300-2025·2024-11-20

    Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk

    Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0299-2025·2024-11-20

    Cryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0133-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling raw yellow onions distributed to food service facilities in six states due to potential E. coli O157:H7 contamination. Use-through dates range from October 16 to November 3, 2024.

    Product
    raw, yellow onions (sliced, diced, slivered, ringed), intended for food service, packaged in plastic bags
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0136-2025·2024-11-20

    Raw yellow onions recalled for potential E. coli O157:H7 contamination

    Taylor Farms Colorado is recalling raw yellow onions due to potential E. coli O157:H7 contamination distributed to food service facilities in CO, KS, MO, NE, NM, and UT.

    Product
    raw, yellow onions (whole unpeeled), intended for food service, in 50-lb corrugated boxes
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0305-2025·2024-11-20

    Anesthesia workstation piston ventilator may fail before or during use

    Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2025·2024-11-20

    Del Monte Pineapple and Apple Salad Recalled for Undeclared Walnut Allergen

    Del Monte Fresh Produce is recalling Pineapple and Apple Salad due to undeclared walnuts (tree nuts). The product may pose a risk to consumers with tree nut allergies.

    Product
    Del Monte Fresh Produce, Pineapple and Apple Salad 4/6.5oz plastic container, four containers per case. Refrigerated. Lot Code 02277101, expiration date 10/10/2024 .
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0433-2025·2024-11-20

    Surgical forceps and clamps recalled due to detachable metal flakes

    AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.

    Product
    Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07
    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-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-0423-2025·2024-11-20

    Halyard Laparotomy GYN Packs recalled due to loose metal flakes

    AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or foreign body reactions.

    Product
    Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
    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-0431-2025·2024-11-20

    Halyard CPT Cardiac Cath Pack Recalled Due to Loose Metal Flakes in Forceps and Clamps

    AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.

    Product
    Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2025·2024-11-20

    Baxter Spectrum IQ Infusion Pump Door May Not Close Fully

    Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0394-2025·2024-11-20

    Medical surgical kits recalled due to loose metal flakes

    AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.

    Product
    Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2025·2024-11-20

    Surgical Instruments Recalled Due to Potential Metal Flake Contamination

    AVID Medical recalled Halyard POST PARTUM TUBAL LIGATION surgical kit components due to loose metal flakes that could detach from sponge forceps and towel clamps. Metal flakes entering a patient's surgical site could cause local or foreign body reactions.

    Product
    Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2025·2024-11-20

    Halyard ANGIO PACK surgical kits recalled for loose metal fragments

    AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.

    Product
    Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2025·2024-11-20

    Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components

    AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.

    Product
    Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2025·2024-11-20

    Stryker smoke evacuation pencil recall: unintended activation risk

    Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.

    Product
    Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation sys
    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-0338-2025·2024-11-20

    IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.

    Product
    SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide