The Recall Desk

Hazard

Device Defect recalls

450 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

351–375 of 450

  • HighFDA (Devices)·Z-1346-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 45 NAMIC Convenience Kits because the needle inner lumen may be too small to accept a 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT, REF Catalog No. 601319810, UPN Product No. H7496013198101 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter ove
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2016·2016-04-06

    Synthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems

    Synthes (USA) Products LLC is voluntarily recalling 42 lots of 4.5 mm LCP Proximal Tibia Plate Systems due to a medical device defect.

    Product
    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2016·2016-03-23

    Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size

    Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.

    Product
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2016·2016-03-09

    Medtronic Perfusion Tubing Packs Recalled Due to Cuvette Safety Alert

    Medtronic is recalling specific lots of Perfusion Tubing Packs because they contain Terumo CVS cuvettes subject to an Urgent Safety Alert.

    Product
    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This pro
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0600-2016·2016-01-13

    KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks

    KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.

    Product
    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connecte
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2780-2015·2015-09-30

    Edwards Lifesciences Recalls ThruPort Knot Pusher Due to Suture Fraying Risk

    Edwards Lifesciences is recalling 759 ThruPort Knot Pusher units because the device's tip design may cause suture fraying or splitting, potentially compromising suture knot integrity during cardiac surgery.

    Product
    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2015·2015-09-09

    Halyard KimVent Suction Catheter Thumb Valve Recall

    Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, compromising the closed suction system.

    Product
    KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper air
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing closed.

    Product
    KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2015·2015-09-09

    Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway safety.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2015·2015-09-09

    Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2015·2015-09-09

    Halyard KimVent Closed Suction Systems Recalled Due to Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

    Product
    KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2015·2015-07-29

    Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints

    Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.

    Product
    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1698-2015·2015-06-17

    HeartWare Ventricular Assist System Recalled for Damaged Power Supply Pins

    HeartWare Inc is recalling HVAD systems due to complaints of damaged or bent connection pins in the power supply ports of the VAD controller.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2015·2015-06-03

    Halyard KimVent Closed Suction System Recalled for Potential Valve Defect

    Halyard Health is recalling specific KimVent Turbo-Cleaning Closed Suction Systems for adults because a defective internal valve may allow air to leak from the ventilator circuit.

    Product
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2015·2015-06-03

    Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk

    Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.

    Product
    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2015·2015-06-03

    Codman 3000 Series Refill Set Recalled for Leaking Needles

    Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.

    Product
    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2015·2015-01-14

    Horiba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues

    Horiba Medical is recalling ABX PENTRA Reagent Containers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling 13,041 boxes of ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diabetes Care is recalling ACCU-CHEK Tender I infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender I Infusion Sets Due to Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender I infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2015·2015-01-07

    ACCU-CHEK Tender II Infusion Sets Recalled for Tubing Detachment Risk

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2015·2014-12-31

    Halyard Health Recalls KimVent Microcuff Endotracheal Tubes Due to Detachment Risk

    Halyard Health is recalling KimVent Microcuff Endotracheal Tubes because the cuff inflation line may detach during use, potentially compromising airway management.

    Product
    KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
    Category
    Medical Device
    Distribution
    Distributed nationwide