The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
451
Critical
10
Severe
67
Most recent
2026-09-23

Of the 451 device defect recalls we have scored against our rubric, 10 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 67 (15%) 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.

326–350 of 451

  • HighFDA (Devices)·Z-0504-2018·2018-02-07

    Beaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield

    Beaver-Visitec is recalling 526,220 units of Optimum Safety Sideport Knives because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2018·2018-02-07

    Beaver Xstar Safety Crescent Blades Recalled Due to Exposed Blade

    Beaver-Visitec is recalling 123,240 units of Xstar Safety Crescent blades because the protective shield retracted, exposing the blade.

    Product
    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0293-2018·2018-01-17

    Edwards Certitude Delivery System Recalled for Molding Overflow Defect

    Edwards Lifesciences is recalling 1,730 units of the Certitude Delivery System due to a molding overflow defect that could detach and embolize into patients.

    Product
    Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), typically during a transapical (TA)…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3127-2017·2017-09-20

    Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core

    Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.

    Product
    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2779-2017·2017-08-09

    Myelotec Video Guided Catheters Recalled for Defective Access Port Body

    Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.

    Product
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2720-2017·2017-07-19

    ICU Medical Recalls Proximale Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 70 units of Proximale Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may develop a leak.

    Product
    PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2241-2017·2017-06-14

    ConvaTec Recalls Non-Rebreathing Masks Due to Potential Valve Defects

    ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks with tubing. The recall is classified as Class II by the FDA.

    Product
    Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1392-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports

    Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic valve design.

    Product
    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1205-2017·2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0819-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragment

    Oscor, Inc. is recalling 45 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 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-0818-2017·2016-12-28

    Medtronic Arrive Braided Transseptal Sheath Recalled Due to Liner Fragmentation

    Oscor, Inc. is recalling 55 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.

    Product
    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 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-0798-2017·2016-12-28

    Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion

    Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.

    Product
    OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 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-0898-2017·2016-12-28

    Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization

    Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.

    Product
    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0382-2017·2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization

    Teleflex Medical is recalling Flexi Nozzle Long sprayers because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pump Systems because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2730-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2160-2016·2016-07-20

    Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance

    Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may reduce stretch resistance, potentially leading to increased coil stretching.

    Product
    Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1688-2016·2016-05-25

    Alcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation

    Alcon is voluntarily recalling 81 LenSx Laser Systems with Corneal Flap Capability due to reports of incomplete corneal flap creation during surgery.

    Product
    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1343-2016·2016-04-13

    AngioDynamics Recalls NAMIC Convenience Kits Due to Needle Lumen Defect

    AngioDynamics is recalling 136 NAMIC Convenience Kits because the needle inner lumen is too small to accept the intended 0.038-inch guidewire.

    Product
    NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2016·2016-04-13

    AngioDynamics Recalls Renown Regional Medical Center Convenience Kits

    AngioDynamics is recalling 100 Renown Regional Medical Center Convenience Kits because the needle inner lumen is too small to accept the intended guidewire.

    Product
    NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to…
    Category
    Medical Device
    Distribution
    Distributed nationwide