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 the agency’s own highest classification or reported deaths or serious injuries, 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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20401–20425 of 27647

  • HighFDA (Devices)·Z-0812-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation

    Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because an inner liner fragment was found during insertion. The recall covers 1,729 units distributed worldwide.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0745-2017·2016-12-21

    BD Vacutainer Push Button Blood Collection Set Recall for Barrel Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.

    Product
    BD 23 G x .75 in. BD Vacutainer¿ Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2017·2016-12-21

    Inovo Purefill Oxygen Compressor Recalled for Operational Failure Risk

    Inovo, Inc. is recalling 117 Inovo Purefill Oxygen Compressor Model PF1100 units because the device can fail during operation.

    Product
    INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2017·2016-12-21

    Steris Recalls Harmony Insight Diagnostic Monitor Support Systems

    Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.

    Product
    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2017·2016-12-21

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage

    Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2017·2016-12-21

    Integra York Metzenbaum Scissors Recalled Due to Packaging Seal Separation

    Integra York PA, Inc. is recalling 50 units of sterile Metzenbaum Scissors because packaging seals may separate, compromising sterility.

    Product
    Metzenbaum Scissors 7, Curved, Sterile The Metzenbaum Scissors 7, Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0751-2017·2016-12-21

    Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect

    Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.

    Product
    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0761-2017·2016-12-21

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators for Unexpected Power Loss

    Physio-Control is recalling 1,399 LIFEPAK 15 monitor/defibrillators because they may power down unexpectedly during use.

    Product
    The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0759-2017·2016-12-21

    Telefac Medical Recalls Weck Facial Closure Systems Due to Detachment Risk

    Teleflex Medical is recalling 2,265 units of Weck Facial Closure Systems because the device wings may partially detach from the shield during use.

    Product
    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2017·2016-12-21

    Teleflex Visistat Skin Staplers Recalled for Sterility Deficiency

    Teleflex Medical is recalling Visistat 35W disposable skin staplers because improper packaging seals mean sterility is not assured.

    Product
    WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2017·2016-12-21

    Prism Medical Carry Bar Recall Due to Breaking Plastic Component

    Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.

    Product
    Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2017·2016-12-21

    Encore Medical Recalls Empowr PS Knee System Box Cut Guides

    Encore Medical is recalling 162 Empowr PS Knee System Box Cut Guides because femoral chipping occurred during surgery.

    Product
    Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2017·2016-12-21

    Elekta Recalls MOSAIQ Oncology Information System Due to Data Saving Error

    Elekta is recalling 47 MOSAIQ Oncology Information System units because edits to particle field definition parameters may not be saved.

    Product
    MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2017·2016-12-21

    Firefly Medical Recalls IVEA 500A Medical Beds Due to Dowel Pin Defect

    Firefly Medical is recalling 239 IVEA 500A medical beds because a dowel pin could slip out, causing the bed to slump and potentially making a patient stumble.

    Product
    IVEA 500A Intended for Med-Surg patient care.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0733-2017·2016-12-21

    Cook Medical Recalls Central Venous Catheter Trays Due to Incorrect Needles

    Cook Medical is recalling 99 units of Spectrum Minocycline/Rifampin Impregnated Central Venous Catheter Trays because they may contain incorrect needles, potentially preventing wire guide passage.

    Product
    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0729-2017·2016-12-21

    Merge Cardio software recalled for potential report matching errors

    Merge Healthcare is recalling Merge Cardio software versions 8.30.0 through 10.1.1 because images sent without an order may be matched to the wrong accession number.

    Product
    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2017·2016-12-21

    GE Healthcare Recalls Avance and Amingo Anesthesia Devices Due to Malfunction Risk

    GE Healthcare is recalling specific Avance CS2, Avance, and Amingo anesthesia devices because they may enter a System Malfunction state if a storage drawer closes with excessive force.

    Product
    GE Healthcare, Avance, Avance CS2, Amingo.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2017·2016-12-21

    GF Health Products Recalls Patriot Homecare Beds Due to Motor Defect

    GF Health Products is voluntarily correcting Patriot homecare beds because contaminated motor housings may crack, potentially causing the head section to fall.

    Product
    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2017·2016-12-21

    Accuray Recalls CyberKnife Systems Due to Unexpected Robot Motion

    Accuray is recalling 40 CyberKnife Robotic Radiosurgery Systems with software version 10.6 due to a potential safety issue involving unexpected treatment robot motion when removing an accessory.

    Product
    CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy…
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-0659-2017·2016-12-14

    SynCardia Freedom Driver System Recalled for Potential Silent Failure

    SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.

    Product
    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0702-2017·2016-12-14

    Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning

    Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.

    Product
    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0727-2017·2016-12-14

    AMD-Ritmed Transparent Dressing Recalled for Sterility Failure

    AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.

    Product
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
    Category
    Medical Device
    Distribution
    4 states