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.

226–250 of 88106

  • ModerateFDA (Devices)·Z-0183-2027·2026-10-21

    Medline recalls CONMED AirSeal Access Port kits due to overpressure alerts

    Medline is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may trigger erroneous overpressure alerts and system venting, potentially delaying or ending surgical procedures.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0145-2027·2026-10-21

    Ferno-Washington Power F2 Powered Fastening System Recall for Firmware Issue

    Ferno-Washington is recalling 319 Power F2 Powered Fastening Systems due to a firmware issue that may cause intermittent loss of powered functionality, potentially delaying patient transport.

    Product
    Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2027·2026-10-21

    Medline Recalls Convenience Kits Containing CONMED AirSeal Access Ports

    Medline is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential for erroneous overpressure alerts and system venting during use.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2027·2026-10-21

    Teva Recalls Metoclopramide Tablets Due to Foreign Object Presence

    Teva Pharmaceuticals is recalling Metoclopramide tablets because they may contain foreign tablets or capsules. The affected products were distributed nationwide.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2027·2026-10-21

    Howmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions

    Howmedica Osteonics Corp. is recalling 582 TS Femoral Prep Trays because reprocessing instructions may lead to residual moisture after sterilization.

    Product
    TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0169-2027·2026-10-21

    Medline recalls cardiac surgery kits with non-conforming cannula components

    Medline Industries is recalling 1,834 cardiac surgery kits because cannula components do not meet ISO 80369-7 dimensional requirements, which may contribute to leaking or breaking during use.

    Product
    1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528O; 4) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2027·2026-10-21

    Medline Recalls Convenience Kits Containing CONMED AirSeal Access Ports

    Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential overpressure alerts and system venting that may delay or end procedures.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0156-2027·2026-10-21

    Steris RAPICIDE PA Part A High-Level Disinfectant Recalled for Pressure Hazard

    Steris is recalling RAPICIDE PA Part A High-Level Disinfectant because a blocked vented cap may cause the bottle to swell and release vapor or liquid, potentially injuring users.

    Product
    RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0186-2027·2026-10-21

    Intelerad IntelePACS Software Recalled for Image Display Mismatch

    Intelerad Medical Systems is recalling IntelePACS software versions because reported and displayed images may not match due to a web-browser issue.

    Product
    IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2027·2026-10-21

    Medline recalls CONMED AirSeal Access Port kits due to pressure alert issues

    Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports due to potential erroneous overpressure alerts and system venting.

    Product
    Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0168-2027·2026-10-21

    Medline surgical convenience kits recalled for non-conforming cannula components

    Medline is recalling 3,125 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0158-2027·2026-10-21

    Gore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling

    W L Gore & Associates is recalling 32 units of GORE VIABIL Short Wire Biliary Endoprosthesis because they may be mislabeled with the incorrect length.

    Product
    Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2027·2026-10-21

    Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components

    Medline is recalling 620 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements, which may cause leaking or breaking during use.

    Product
    Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2027·2026-10-21

    Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent

    Boston Scientific is recalling 403 units of NaviFlex LW Pusher and Advx Panc. Stent devices due to an incorrect manufacturing feature.

    Product
    NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0093-2027·2026-10-21

    Stewart's Shops Ice Cream Recalled for Potential Metal Contamination

    Stewart's Shops is recalling 10,760 units of Vanilla Chocolate Strawberry Ice Cream due to a potential foreign object hazard involving pieces of metal.

    Product
    Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon (1.89 L), UPC: 0 82086 44377 3
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0163-2027·2026-10-21

    Cook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect

    Cook Incorporated is recalling 97 Williams Cystoscopic Injection Needles because a component may not be correctly seated, potentially causing inadequate treatment.

    Product
    Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0175-2027·2026-10-21

    Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components

    Medline is recalling 235 surgical convenience kits because the cannula components do not meet ISO 80369-7 dimensional requirements and may leak or break during use.

    Product
    Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615J; 3) CV BASIN PACK-LF, Medline product number/SKU DYNJ0538615L.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0089-2027·2026-10-21

    Holsum Spinach Flour Tortillas Recalled for Undeclared Food Dyes

    Holsum De Puerto Rico, Inc. is recalling Spinach Flour Tortillas due to undeclared FD&C Blue No. 1 and FD&C Yellow No. 5.

    Product
    Holsum Spinach Flour Tortillas Large, 8 count (20 oz.) UPC: 810023430629
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0149-2027·2026-10-21

    BioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination

    BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panel Plus kits due to potential contamination that could cause false positive results.

    Product
    Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2027·2026-10-21

    Microgenics Recalls MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control

    Microgenics Corporation is recalling MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control products due to vial-to-vial variability that may delay patient PTH results.

    Product
    MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0148-2027·2026-10-21

    BioFire FilmArray Pneumonia Panel Recalled for Potential Contamination

    BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panels due to potential contamination that could result in false positive test results.

    Product
    Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from…
    Category
    Medical Device
    Distribution
    Distributed nationwide