Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,800
Critical: 31
Severe: 370
Most recent: 2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 malfunction 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.

1251–1275 of 1800

HighFDA (Devices)·Z-0048-2018·2017-11-01
GORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk
W.L. Gore & Associates is recalling 12,197 GORE TAG Thoracic Endoprosthesis units worldwide due to a risk of incomplete or partial deployment during endovascular procedures.
Product
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-3228-2017·2017-10-04
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3231-2017·2017-10-04
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling 72 Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3106-2017·2017-10-04
Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues
Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.
Product
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3230-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients wh
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3233-2017·2017-10-04
Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI
Sorin Group is recalling 68 Platinium CRT-D devices due to a possibility of overconsumption of the device following electrostatic discharge or an MRI scan.
Product
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3232-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3137-2017·2017-09-27
Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.
Product
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3133-2017·2017-09-20
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.
Product
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3117-2017·2017-09-20
Zimmer Biomet Recalls ROSA Surgical Device Foot Switches
Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.
Product
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electrom
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3071-2017·2017-09-06
Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects
Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.
Product
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3054-2017·2017-08-30
Medtronic AxiEM ENT Suction Devices Recalled for Verification Failure
Medtronic is recalling 60 reusable ENT suction instruments because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3052-2017·2017-08-30
Medtronic Curved Suction 70 Recalled for Verification Failure
Medtronic is recalling 149 Curved Suction 70 ENT instruments because they fail required pre-use verification checks.
Product
Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3051-2017·2017-08-30
Medtronic ENT Suction Devices Recalled for Verification Failure
Medtronic Navigation is recalling 277 reusable ENT suction instruments because they fail pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.
Product
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3057-2017·2017-08-30
Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure
Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.
Product
Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3069-2017·2017-08-30
Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect
Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.
Product
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead h
Category
Medical Device
Distribution
47 states
SevereFDA (Devices)·Z-3038-2017·2017-08-23
Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk
Boston Scientific is recalling approximately 9,200 Emblem MRI S-ICD devices because memory corruption may cause the device to deliver an atypical amount of energy.
Product
EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3041-2017·2017-08-23
Baxter HomeChoice Pro Automated Peritoneal Dialysis System Recall
Baxter is recalling HomeChoice Pro Automated PD systems because damaged cassettes may allow air delivery to patients.
Product
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal di
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3040-2017·2017-08-23
Baxter HomeChoice Automated PD System Recalled for Air Delivery Risk
Baxter is recalling HomeChoice Automated PD systems because damaged cassettes may allow the device to deliver air to patients.
Product
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialys
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2755-2017·2017-08-02
Medtronic Visualase Cooled Laser Applicator System Recalled for Seal Defect
Medtronic is recalling 214 units of the Visualase Cooled Laser Applicator System because the cap may fail to seal, causing saline leaks.
Product
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag. Medtronic Navigation, Inc. Louisville, CO 80027
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2695-2017·2017-07-19
St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators
St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.
Product
Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic cir
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2682-2017·2017-07-19
ICU Recalls Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2017·2017-07-05
Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors
Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.
Product
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2017·2017-06-28
Medtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting insulin delivery.
Product
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2602-2017·2017-06-28
Medtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction
Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.
Product
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Category
Medical Device
Distribution
0 states