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.

426–450 of 451

SevereFDA (Devices)·Z-1850-2013·2013-08-14
Hospira Recalls Secondary Blood Sets Due to Piercing Pin Defect
Hospira Inc. is recalling 672 units of secondary blood sets because the piercing pin may puncture the outer wall of blood bags during insertion.
Product
List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (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
SevereFDA (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
SevereFDA (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-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…
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…
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…
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…
Category
Medical Device
Distribution
40 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-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-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-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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (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
SevereFDA (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-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-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
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
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