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.

1751–1775 of 1800

SevereFDA (Devices)·Z-0172-2013·2012-11-07
Ventlab Stat-Check Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of Stat-Check Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2013·2012-11-07
Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage
Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.
Product
AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversib
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2013·2012-11-07
Ventlab Safe Spot Infant Resuscitator Recalled for Valve Leakage
Ventlab is recalling Safe Spot Infant Resuscitators due to possible volume leakage through the inlet valve during use.
Product
Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2013·2012-11-07
Ventlab Premium Small Adult Resuscitator Recalled for Valve Leakage
Ventlab Corporation is recalling 14,602 Premium Small Adult Resuscitators due to a defect that may cause volume leakage through the inlet valve during use.
Product
Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0168-2013·2012-11-07
Alphatec Spine Recalls Illico MIS Posterior Fixation System Screws
Alphatec Spine is recalling 209 Illico MIS Posterior Fixation System screws because a guide-wire fit issue renders them nonfunctional.
Product
ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spina
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0070-2013·2012-10-31
Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunctions
Hospira is recalling Symbiq Two Channel Infusers because the touchscreen may fail to respond or register incorrect values, potentially causing medication delivery errors.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0069-2013·2012-10-31
Hospira Symbiq Infusion Pump Recalled for Touchscreen Malfunction
Hospira is recalling 19,614 Symbiq One Channel Infusion Pumps because the touchscreen may fail to respond or register incorrect values, potentially leading to medication dosing errors.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0137-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewires Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes the wires to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0136-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0057-2013·2012-10-24
Ethicon Recalls Hemorrhoidal Circular Staplers Due to Firing Defect
Ethicon Endo-Surgery is recalling specific lots of PROXIMATE PPH and Transtar circular staplers because a firing defect may cause incomplete staple formation.
Product
Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resectio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0072-2013·2012-10-24
MOOG Medical Devices Recalls Curlin Infusion Administration Sets
MOOG Medical Devices Group is recalling 12,000 Curlin Infusion Administration Sets due to an incomplete previous recall regarding unclearable Air-In-Line alarms.
Product
***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0075-2013·2012-10-24
Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect
The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.
Product
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0049-2013·2012-10-17
Terumo Sarns Centrifugal System Battery Backup Recall for Malfunctions
Terumo CVS is recalling Sarns Centrifugal System batteries due to reports of charging and operational failures that could cause loss of arterial flow.
Product
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-0015-2013·2012-10-17
Baxter Recalls Clearlink System Buretrol Solution Sets Due to Valve Malfunction
Baxter Healthcare is recalling 488,504 units of Clearlink System Buretrol Solution Sets because the ball-valve feature may allow air to enter the tubing.
Product
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0012-2013·2012-10-17
Baxter Buretrol Solution Set Recalled for Potential Air Inflow
Baxter is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing at the completion of a dose.
Product
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular acces
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0013-2013·2012-10-17
Baxter Buretrol Solution Set Recalled Due to Ball-Valve Malfunction
Baxter Healthcare is recalling Buretrol Solution Sets because the ball-valve feature may allow air to flow into the tubing.
Product
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular syste
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2480-2012·2012-10-10
Zimmer Recalls MIS Slotted Femoral Head Provisional Medical Devices
Zimmer, Inc. is recalling MIS 12/14 Slotted Femoral Head Provisional devices due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.
Product
00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS 12/14 Slotted Femoral Head Provisional +0X26 00780302603 MIS 12/14 Slotted Femoral Head Provisional +3.5X26 00780302604 MIS 12/14 Slotted Femoral Head Provisional +7X26 00780302605 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2484-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling provisional femoral heads used in hip surgery due to reports of sub-optimal fit with mating components.
Product
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2479-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling specific provisional femoral heads used in hip surgery due to reports of improper fit with mating components.
Product
00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 12/14 Slotted Femoral Head Provisional +3.5X22 The provisional heads replicate final femoral implant geometry and are used to trial range
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2481-2012·2012-10-10
Zimmer Recalls Provisional Femoral Heads Due to Fit Issues
Zimmer, Inc. is recalling MIS and VerSys provisional femoral heads due to reports of sub-optimal fit with mating components, which can lead to intraoperative dislodging.
Product
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2012·2012-10-10
Biomet Recalls OptiLock Screw Inserters Due to Fit Issues
Biomet is recalling 268 OptiLock 2.7 mm Screw Inserters because they may not properly lock into screw heads, posing a risk of improper fixation.
Product
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0008-2013·2012-10-10
Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error
Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.
Product
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2450-2012·2012-10-03
Abbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues
Abbott Vascular is recalling Armada 35 and Armada 35 LL PTA Catheters because some devices may have difficulty inflating or deflating.
Product
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2379-2012·2012-09-26
FDA Recalls HALO Flex Energy Generators Due to Standby Mode Failure
The FDA is recalling HALO Flex Energy Generators because they may fail to enter standby mode upon startup, rendering them unusable for patient care.
Product
HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleedi
Category
Medical Device
Distribution
Distributed nationwide