The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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4976–5000 of 13512

  • HighFDA (Devices)·Z-3212-2024·2024-10-02

    Cervical disc replacement recalled for foreign contamination in assembly

    Centinel Spine is recalling the Prodisc C SK cervical disc replacement due to blue discoloration on the inlay observed during assembly. This discoloration is a foreign contaminant that was not fully evaluated in manufacturing validations.

    Product
    prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3227-2024·2024-10-02

    Endovascular AAA Packs Recalled Due to Sterilization Process Defect

    American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3252-2024·2024-10-02

    Biodesign Fistula Plug recalled for expiring before printed expiration date

    Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.

    Product
    Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3223-2024·2024-10-02

    Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.

    Product
    Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3286-2024·2024-10-02

    WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2024·2024-10-02

    Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery

    Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.

    Product
    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3226-2024·2024-10-02

    Medical Pacemaker Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.

    Product
    PACEMAKER PACK, SLCV01J; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3240-2024·2024-10-02

    Surgical convenience kit sterilization assurance cannot be confirmed

    American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.

    Product
    Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3232-2024·2024-10-02

    Medical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed

    American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.

    Product
    Shoulder, SESH18I; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2024·2024-10-02

    Boston Scientific Esophageal Stent Systems Recalled for Catheter Detachment Risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2024·2024-10-02

    BD Phoenix M50 may misidentify E. coli bacteria in clinical samples

    The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.

    Product
    BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3260-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration

    Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3194-2024·2024-10-02

    Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop

    Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3250-2024·2024-10-02

    Cook Biotech Biodesign Fistula Plug implants recalled for premature expiration

    Cook Biotech is recalling Biodesign Fistula Plug C-FPB-0.4 implants because products expire before their printed expiration dates.

    Product
    Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3295-2024·2024-10-02

    Boston Scientific Agile Esophageal Stent Recall: Catheter Tip Detachment Risk

    Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.

    Product
    AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of conc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3279-2024·2024-10-02

    Boston Scientific esophageal stent systems recalled for catheter tip detachment

    Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3266-2024·2024-10-02

    WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment

    Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.

    Product
    WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3259-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug units expire before labeled date

    Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3280-2024·2024-10-02

    FDA Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment Risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems (516 units) due to potential for delivery catheter tip detachment during stent placement procedures.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3136-2024·2024-10-02

    Cardiac Support Device Software Defect Risks Hemodynamic Instability

    Datascope Corp. is recalling the CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP globally due to software defects risking hemodynamic instability and clinical data transmission failure.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3245-2024·2024-10-02

    FDA Recalls Surgical Instrument Handle That May Break During Use

    The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.

    Product
    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3238-2024·2024-10-02

    Vaginal Delivery Medical Convenience Kit Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.

    Product
    Vaginal Delivery, ASDV25B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3216-2024·2024-10-02

    ACUSON Redwood Ultrasound Systems Recall for Software Unit Conversion Error

    Siemens ACUSON Redwood ultrasound systems may display measurements 10 times smaller than actual if operators change the software from factory defaults to milliliters per second or minute. This could lead to misdiagnosis and poor patient management.

    Product
    ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3251-2024·2024-10-02

    Cook Biotech Fistula Plug recalled for expiring before labeled date

    Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.

    Product
    Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
    Category
    Medical Device
    Distribution
    Distributed nationwide