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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3876–3900 of 5111

  • 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-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 intend
    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-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-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-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) cons
    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-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, incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
  • 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-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-0006-2017·2016-10-19

    HeartWare HVAD Pump Recalled for Foreign Material in Driveline Connector

    HeartWare is recalling 344 HVAD pumps worldwide because foreign material in the driveline connector could cause electrical faults.

    Product
    HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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 failu
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0067-2017·2016-10-19

    Brathwaites Oliver Medical Recalls Introes Pocket Bougie Endotracheal Tube Introducers

    Brathwaites Oliver Medical is recalling Introes Pocket Bougie endotracheal tube introducers because the device may break during intubation.

    Product
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2917-2016·2016-10-12

    Cardinal Health Recalls Blue Impervious Gowns for Flammability Defect

    Cardinal Health is recalling Blue Impervious Gowns, X-Large, because they failed to meet federal flammability standards for vinyl plastic film.

    Product
    BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0040-2017·2016-10-12

    Trumpf Medical Systems Recalls TruSystem Mobile Operating Columns

    Trumpf Medical Systems is recalling 84 TruSystem mobile operating columns because they may unexpectedly descend approximately 20 centimeters.

    Product
    Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top
    Category
    Medical Device
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-2783-2016·2016-10-05

    Anspach Effort Recalls Light Adaptors for Small Battery Drive Devices

    The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.

    Product
    Light Adaptor for Small Battery Drive and Small Battery Drive II.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2883-2016·2016-10-05

    Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2880-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2790-2016·2016-09-21

    Hospira MedNet Software Recall for Incorrect Bolus Calculations

    Hospira is recalling MedNet 6.1 software used with SapphirePlus infusion pumps because it may calculate incorrect bolus amounts for drugs in Million Units.

    Product
    Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible co
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2693-2016·2016-09-14

    MicroPort Advance II Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states