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.

1326–1350 of 1800

HighFDA (Devices)·Z-0355-2017·2016-11-09
Unomedical Comfort Infusion Sets Recalled for Tubing Detachment Risk
Unomedical As is recalling 1.3 million Comfort infusion sets used with insulin pumps due to a risk of tubing detachment.
Product
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 4
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0356-2017·2016-11-09
Unomedical Recalls Insulin Infusion Sets Due to Tubing Detachment Risk
Unomedical As is voluntarily recalling 664,000 Contact Detach infusion sets used with insulin pumps due to a risk of tubing detachment.
Product
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0323-2017·2016-11-09
Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard
Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.
Product
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualiz
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0322-2017·2016-11-09
Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction
Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.
Product
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visua
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0353-2017·2016-11-09
Hospira Recalls Symbiq Infusion Pumps Due to Backup Battery Failure
Hospira is recalling 20,311 Symbiq One Channel Infusion Pumps due to a backup battery failure caused by incorrect component installation on some power supply boards.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2017·2016-11-09
Hospira Symbiq Infusion Pumps Recalled for Backup Battery Failure
Hospira is recalling Symbiq Two Channel Infusers due to a backup battery failure caused by incorrect component installation on some power supply boards.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0114-2017·2016-11-02
Sequent Medical Recalls VIA 27 Microcatheter Due to Re-sheathing Defect
Sequent Medical is recalling 618 units of the VIA 27 Microcatheter because the device may not adequately re-sheath interventional devices as designed.
Product
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, perip
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0317-2017·2016-11-02
Zimmer Biomet Recalls Patellofemoral Joint Prosthesis Milling Handpieces
Zimmer Biomet is recalling 703 Patellofemoral Joint Prosthesis Milling Handpieces because they may be inoperable due to lack of preventative maintenance, potentially delaying surgery.
Product
Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0004-2017·2016-10-26
Leonhard Lang Recalls Skintact Defibrillation Electrodes Due to Connection Delay
Leonhard Lang is recalling Skintact DF29N defibrillation electrodes because they may not connect to Welch Allyn AED 10 devices promptly, delaying life-saving treatment.
Product
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0296-2017·2016-10-26
Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters
Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.
Product
Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0120-2017·2016-10-26
Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect
Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Procedure Packs because the vitrectomy cutters do not operate within the correct pressure pulse specifications.
Product
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0136-2017·2016-10-26
Hand Biomechanics Lab Recalls Agee WristJack Fracture Reduction Systems
Hand Biomechanics Lab Inc is recalling 65 Agee WristJack Fracture Reduction Systems because a molded beam is slightly larger than optimal, which may make surgical adjustments difficult.
Product
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0093-2017·2016-10-26
Tearscience Recalls LipiFlow Thermal Pulsation System Activators Due to Error Condition
Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators because the device may automatically stop treatment during patient use.
Product
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cys
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0014-2017·2016-10-12
Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect
Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.
Product
Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2017·2016-10-12
Argon Medical Devices Recalls MicroStic Plus Sheaths Due to Dilator Hub Defect
Argon Medical Devices is recalling 200 units of MicroStic Plus sheaths because the dilator hub is too small to secure the dilator to the sheath.
Product
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2886-2016·2016-10-05
Spacelabs Xhibit Telemetry Receiver Recall for System Lockups
Spacelabs Healthcare is recalling Xhibit Telemetry Receivers because the system may go offline or lock up, potentially failing to display alarms.
Product
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2894-2016·2016-10-05
Zyno Medical Administration Set Recalled for Potential Filter Leaking
Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.
Product
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2874-2016·2016-09-28
Hospira LifeCare PCA 3 Pumps Recalled for Screw Rotation Error
Hospira is recalling 69 LifeCare PCA 3 pumps due to a screw rotation error that stops infusion and triggers an alarm.
Product
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2854-2016·2016-09-28
EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect
EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.
Product
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2873-2016·2016-09-28
Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error
Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.
Product
LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2729-2016·2016-09-14
Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm
Hospira Inc. is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.
Product
Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose 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 b
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2722-2016·2016-09-14
Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm
Hospira Inc. is recalling 357,778 Plum A+ Hyperbaric Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruptions.
Product
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose 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, micro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2725-2016·2016-09-14
Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm
Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.
Product
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose 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 b
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2726-2016·2016-09-14
Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm
Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.
Product
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2723-2016·2016-09-14
Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm
Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.
Product
Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose 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 ba
Category
Medical Device
Distribution
Distributed nationwide