Hazard

Device Failure recalls

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

What the numbers show

Total: 881
Critical: 30
Severe: 255
Most recent: 2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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.

801–825 of 881

HighFDA (Devices)·Z-0389-2014·2013-12-04
Mindray Recalls V Series Patient Monitors Due to Power Pin Issue
Mindray is recalling V Series Patient Monitors because power pins may lose tension, causing the screen to go blank or shut down.
Product
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the V Series include the monitoring
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0391-2014·2013-12-04
Synthes Matrix Coronal Bender Recall Due to Tip Breakage
Synthes USA is recalling 209 Matrix 5.5mm Coronal Benders because tips broke during use. The devices are used for spinal stabilization.
Product
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine throug
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0396-2014·2013-12-04
Synthes Titanium Spinal Locking Caps Recalled for Post-Operative Loosening
Synthes USA is recalling 745 Titanium Minimally Invasive Reduction Screw System Locking Caps due to a risk of post-operative loosening if the construct is mis-aligned during final tightening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0395-2014·2013-12-04
Synthes Polyaxial Screw Body Recalled for Potential Post-Operative Loosening
Synthes USA is recalling 757 units of Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Bodies due to reported complaints of post-operative locking cap loosening.
Product
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0261-2014·2013-11-27
Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.
Product
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0264-2014·2013-11-27
Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0268-2014·2013-11-27
Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0186-2014·2013-11-20
Fresenius Medical Care Recalls Combiset Blood Lines for Hemodialysis
Fresenius Medical Care is recalling 508,029 cases of Combiset Blood Lines for hemodialysis because connections may disconnect if not tightened correctly, leading to blood loss.
Product
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0283-2014·2013-11-20
Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin
Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0290-2014·2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0151-2014·2013-11-13
Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure
Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.
Product
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2014·2013-10-23
Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk
Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2014·2013-10-23
Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion
Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2014·2013-10-09
H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing
H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.
Product
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2013·2013-10-02
Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2200-2013·2013-09-25
Medtronic Recalls T8 Removal Heads Due to Incorrect Hardness Specification
Medtronic is recalling nine T8 Removal Heads used in spinal surgery due to incorrect hardness specifications that could cause the tool to fail during implant removal.
Product
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1982-2013·2013-08-28
EndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss
EndoGastric Solutions is recalling EsophyX2 devices because of reports of loss of tissue mold control, which required surgical removal in one case.
Product
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1836-2013·2013-08-07
St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
Product
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1756-2013·2013-07-31
LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking
LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.
Product
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1757-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 18x09 due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1790-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 13 Brivo NM615 nuclear medicine imaging systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1769-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leaking
LeMaitre Vascular is recalling two units of AlboGraft Woven with Collagen vascular grafts because blood may leak from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 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-1766-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Blood Leakage
LeMaitre Vascular is recalling AlboGraft Woven with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 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-1685-2013·2013-07-17
Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.
Product
Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1678-2013·2013-07-17
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.
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