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.

426–450 of 450

  • HighFDA (Devices)·Z-1853-2013·2013-08-14

    Hospira Blood Sets Recalled Due to Potential Bag Puncture Risk

    Hospira is recalling 240 blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.

    Product
    List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1760-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding

    LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1762-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding

    LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.

    Product
    AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1758-2013·2013-07-31

    LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking

    LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.

    Product
    AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1677-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1322-2013·2013-05-22

    Edwards Lifesciences Recalls Proplege Coronary Sinus Catheters Due to Leakage

    Edwards Lifesciences is recalling Proplege Coronary Sinus Catheters, model PR9, because of confirmed blood leakage through the hemostasis valve in the kitted introducer.

    Product
    Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2013·2013-04-24

    Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift

    Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.

    Product
    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1017-2013·2013-04-03

    Medtronic Archer Super Stiff Guidewire Recalled for Coating Separation Risk

    Medtronic is recalling Archer Super Stiff Guidewires because the PTFE coating may separate from the wire during use.

    Product
    Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0757-2013·2013-02-06

    Abbott Vascular Recalls RX Accunet Embolic Protection System Lots

    Abbott Vascular is recalling specific lots of the RX Accunet Embolic Protection System because the peel-away sheath may be difficult to remove due to higher than normal wall thickness.

    Product
    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2013·2013-01-02

    Greatbatch Medical Recalls MobiCath Bi-Directional Guiding Sheaths Due to Liner Anomalies

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the cor
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-0456-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0460-2013·2012-12-12

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Plastic Flash

    Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.

    Product
    18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0458-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.

    Product
    24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0288-2013·2012-11-21

    Trivascular Recalls Fill Polymer Kits Due to Potential Stopcock Leaks

    Trivascular is recalling 41 units of Fill Polymer Kits in European distributor inventory due to potential stopcock cracks that may cause leaks.

    Product
    TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2013·2012-11-07

    Ventlab Pro-5000 Adult Resuscitator Recalled for Volume Leakage

    Ventlab Corporation is recalling 14,602 Pro-5000 Series Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.

    Product
    Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2013·2012-11-07

    Ventlab Premium Small Child Resuscitator Recalled for Valve Leakage

    Ventlab Corporation is recalling 14,602 Premium Small Child Resuscitators due to possible volume leakage through the inlet valve during compressions.

    Product
    Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2013·2012-11-07

    Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

    Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.

    Product
    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0066-2013·2012-10-24

    ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Driver Tip Separation

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after the implant is inserted.

    Product
    "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2456-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Universal Light Source Devices

    ConMed Linvatec is recalling 57 Xenon Universal Light Source units used for endoscopic illumination due to a Class II recall.

    Product
    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Light Sources for Endoscopic Procedures

    ConMed Linvatec is recalling LS7700 and LS7600 Xenon Light Sources used to illuminate endoscopes during medical procedures.

    Product
    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2012·2012-09-26

    Kimberly-Clark MIC Safety PEG Kit Recall Due to Guidewire Size Issue

    Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits because the placement guidewire is too large to pass through the introducer needle.

    Product
    Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2012·2012-09-26

    Kimberly-Clark MIC PEG Kit Recall Due to Placement Guidewire Size Issue

    Kimberly-Clark is recalling MIC PEG Kits - Pull Type because the placement guidewire is too large to pass through the introducer needle.

    Product
    Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2012·2012-07-11

    Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices

    Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.

    Product
    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1883-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of some tips can be dislodged.

    Product
    X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
    Category
    Medical Device
    Distribution
    Distributed nationwide