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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20776–20800 of 27682

  • SevereFDA (Devices)·Z-0004-2017·2016-10-26

    Leonhard Lang Recalls Skintact Defibrillation Electrodes Due to Connection Delay

    Leonhard Lang is recalling Skintact DF29N defibrillation electrodes because they may not connect to Welch Allyn AED 10 devices promptly, delaying life-saving treatment.

    Product
    Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0119-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Core Essentials Procedure Packs because the vitrectomy cutters do not operate within correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0231-2017·2016-10-26

    Windstone Medical Recalls Major General Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0260-2017·2016-10-26

    Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0054-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass RX Dual Access Catheters Due to Manufacturing Defect

    Vascular Solutions is recalling Twin-Pass RX Dual Access Catheters because excess manufacturing material may remain at the tip or within the distal lumen.

    Product
    Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0141-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.

    Product
    Anterior Cervical Fusion Pack, Kit part numbers: AMS2502 and AMS2502(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.

    Product
    Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0053-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Catheters Due to Manufacturing Material

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the tip or in the distal lumen.

    Product
    Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0005-2017·2016-10-26

    Heartware Ventricular Assist System Controller Recall for Loose Connector Ports

    Heartware, Inc. is recalling Ventricular Assist System Controllers due to loose connector ports. The recall affects 4,235 units worldwide, including 7,272 in the U.S.

    Product
    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0055-2017·2016-10-26

    Vascular Solutions Recalls Twin-Pass Dual Access Catheters Due to Manufacturing Residue

    Vascular Solutions is recalling Twin-Pass dual access catheters because excess manufacturing material may remain at the catheter tip or within the distal rapid exchange lumen.

    Product
    Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0044-2017·2016-10-26

    Teleflex Medical Recalls Willy Rusch Tracheostomy Tube Sets

    Teleflex Medical is recalling Willy Rusch Tracheostomy Tube Sets because the connector may disconnect from the tube during use.

    Product
    Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2017·2016-10-26

    Windstone Medical Packaging Recalls Endoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 304 Endoscopy Packs because disposable gloves in the kits may have splits or holes that compromise sterility.

    Product
    Endoscopy Pack, Kit number PSS1646 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0290-2017·2016-10-26

    RTI Surgical Recalls Streamline OCT Spinal Rods Due to Cracks

    RTI Surgical is voluntarily recalling 66 units of Streamline OCT spinal rods due to potential cracks that could reduce strength and cause patient injury.

    Product
    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2017·2016-10-26

    Windstone Medical Packaging Recalls Extremity Tray Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 816 Extremity Tray kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Extremity Tray, Kit number AMS1200(B and AMS1200(C convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0127-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices

    X Spine Systems is recalling 1,186 Calix T PEEK Lumbar System trial devices because components may detach and lodge in the intervertebral space during surgery.

    Product
    Calix T PEEK Lumbar System, TLIF Trial
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0233-2017·2016-10-26

    Windstone Medical Packaging Recalls Major Laparotomy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 12 Major Laparotomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0126-2017·2016-10-26

    X Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps

    X Spine Systems is recalling 195 units of Calix T PEEK Lumbar System TLIF Rasps because the tools may detach and become lodged in the surgical site.

    Product
    Calix T PEEK Lumbar System, TLIF Rasp
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0263-2017·2016-10-26

    Windstone Medical Recalls Plastic Packs with Defective Gloves

    Windstone Medical Packaging is recalling 204 plastic packs used in general surgery because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0253-2017·2016-10-26

    Windstone Medical Recalls Ortho Kits Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 145 Ortho Kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2017·2016-10-26

    Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2017·2016-10-26

    Windstone Medical Recalls Basic Surgery Kits Due to Sterility Compromise

    Windstone Medical Packaging is recalling 6,381 Basic Pack surgery kits because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2017·2016-10-26

    Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters

    Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.

    Product
    Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0191-2017·2016-10-26

    Windstone Medical Recalls Foot Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 85 Foot Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0190-2017·2016-10-26

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.

    Product
    Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide