Hazard

Device Failure recalls

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

What the numbers show

Total: 882
Critical: 29
Severe: 301
Most recent: 2026-09-23

Of the 882 device failure recalls we have scored against our rubric, 29 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 301 (34%) 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 failure 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.

626–650 of 882

HighFDA (Devices)·Z-0636-2018·2018-02-28
FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure
The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.
Product
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0564-2018·2018-02-21
Kalila Medical Recalls Vado Bi-Directional Steerable Sheaths Due to Torn Liner
Kalila Medical is recalling 261 Vado Bi-Directional Steerable Sheaths because torn liner material was detected during internal testing, potentially caused by manufacturing damage.
Product
Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0596-2018·2018-02-21
Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads
Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.
Product
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.
Product
Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2018·2018-01-24
Zoll LifeVest Wearable Defibrillator Recalled for Defibrillation Shock Failure Risk
Zoll Manufacturing Corp. is recalling 33,670 LifeVest Wearable Defibrillators due to an incorrect service code that may prevent the device from detecting critical defects, potentially leading to defibrillation shock failure.
Product
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0266-2018·2017-12-27
Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk
Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.
Product
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2018·2017-12-27
Terumo Overpressure Safety Valve Recalled Due to No Flow Reports
Terumo CVS is recalling 297,222 Overpressure Safety Valves worldwide after receiving reports of no flow through the device.
Product
TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0072-2018·2017-11-29
Spacelabs Arkon Anesthesia Workstation Recalled for Mechanical and Display Failures
Spacelabs Healthcare is recalling 110 Arkon Anesthesia Workstations due to failures in ventilation, gas delivery, and display alarms.
Product
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0003-2018·2017-10-18
St Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.
Product
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3019-2017·2017-08-23
Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity
Cyberonics is recalling 396 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause the devices to lose power faster than expected.
Product
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3031-2017·2017-08-23
ICU Medical Recalls Plum 360 Infusion Systems Due to Module Disengagement Risk
ICU Medical is recalling 68,559 Plum 360 Infusion Systems because the Connectivity Engine Module may disengage, causing the unit to shut down without an alarm and interrupting therapy.
Product
Plum 360 Infusion System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2017·2017-08-09
Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk
Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.
Product
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Category
Medical Device
Distribution
40 states
CriticalFDA (Devices)·Z-2736-2017·2017-08-02
Maquet CS 100i Intra-Aortic Balloon Pump Recalled Due to Device Failure
Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.
Product
CS 100i Intra-Aortic Balloon Pump
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2737-2017·2017-08-02
Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure
Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.
Product
CS 100 Intra-Aortic Balloon Pump
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2738-2017·2017-08-02
Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure
Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.
Product
CS 300 Intra-Aortic Balloon Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2733-2017·2017-07-19
Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk
Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.
Product
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE…
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-2714-2017·2017-07-19
ArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure
Arjo, Inc. is recalling 40,675 Flowtron ACS900 medical pumps worldwide because the device may fail to deflate the calf garment as intended without triggering an alarm.
Product
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2017·2017-07-05
Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage
Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.
Product
High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2289-2017·2017-06-14
Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2198-2017·2017-06-07
Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns
Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.
Product
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2197-2017·2017-06-07
Acumed Recalls Slide-Loc Anatomic Radial Head System Due to Performance Issues
Acumed LLC is voluntarily removing the Slide-Loc Anatomic Radial Head System from the market due to complaints about instrumentation performance, trial design, and implant dissociations.
Product
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2051-2017·2017-05-31
St. Jude Medical HeartMate II LVAS Software and Hardware Update Recall
St. Jude Medical is updating software and hardware for HeartMate II LVAS devices to facilitate the exchange to a backup controller.
Product
HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2164-2017·2017-05-31
Datascope Recalls Intra-Aortic Balloon Catheters Due to Tip Seal Leak Failures
Datascope is voluntarily removing 996 units of SENSATION PLUS Intra-Aortic Balloon Catheters due to internal pressure testing failures related to tip seal leaks.
Product
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2112-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.
Product
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.
Product
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are…
Category
Medical Device
Distribution
Distributed nationwide