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.

676–700 of 882

HighFDA (Devices)·Z-0808-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 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-0814-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 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-0800-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 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-0795-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 76 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 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-0807-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 34 units of the Adelante Breezeway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 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-0891-2017·2016-12-28
Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery
Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.
Product
Optimus Fixed Awl
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0811-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Fragmentation
Oscor, Inc. is recalling 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 GLOBAL Catalog # 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
CriticalFDA (Devices)·Z-0659-2017·2016-12-14
SynCardia Freedom Driver System Recalled for Potential Silent Failure
SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.
Product
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0358-2017·2016-11-09
Unomedical Comfort 5+5 Insulin Infusion Pump Sets Recalled for Tubing Detachment
Unomedical As is recalling 22,114 Comfort 5+5 insulin infusion pump sets because the tubing may detach. The recall covers products distributed in the US and internationally.
Product
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2651-2016·2016-08-31
Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk
Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.
Product
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2650-2016·2016-08-31
Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.
Product
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2646-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Adhesive Bonding Defect
Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2541-2016·2016-08-24
TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues
TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.
Product
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2544-2016·2016-08-24
LeMaitre Vascular Recalls 1.5 mm HYDRO Valvulotome Due to Wire Detachment
LeMaitre Vascular is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.
Product
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2349-2016·2016-08-17
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.
Product
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2348-2016·2016-08-17
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.
Product
STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2096-2016·2016-07-27
Stryker Recalls Angiographic Catheters Due to Tip Breakage
Stryker is recalling 167 AngioDynamics Soft Vu Omni Flush Angiographic Catheters because the tips broke off before use.
Product
AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2166-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 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-2179-2016·2016-07-20
Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
Product
Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 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-2171-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 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-2170-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 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-2162-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing defects may have damaged internal sutures, leading to increased coil stretching.
Product
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 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-2169-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of the internal sutures.
Product
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 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-2181-2016·2016-07-20
Stryker Target Detachable Coils Recalled for Manufacturing Defect
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 HELICAL NANO 2MM X 6CM MODEL Number:M0035452060 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
SevereFDA (Devices)·Z-2100-2016·2016-07-06
Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk
Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.
Product
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
Category
Medical Device
Distribution
Distributed nationwide