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.

1301–1325 of 1800

HighFDA (Devices)·Z-1390-2017·2017-03-08
Cook Inc. Recalls Flexor Radial Access Sets Due to Blood Loss Reports
Cook Inc. is recalling 41,975 Flexor Radial Access Sets because a specific hemostatic valve design is associated with increased reports of blood loss.
Product
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-1389-2017·2017-03-08
Cook Inc. Recalls Check-Flo Hemostasis Assemblies Due to Blood Loss Reports
Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.
Product
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-1393-2017·2017-03-08
Cook Inc. Recalls TriForce Peripheral Crossing Sets Due to Blood Loss Reports
Cook Inc. is recalling 1,875 TriForce Peripheral Crossing Sets because a specific valve design is associated with increased reports of blood loss.
Product
TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interv
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-1387-2017·2017-03-08
Cook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports
Cook Inc. is recalling 884 Check-Flo Performer Introducers because a specific valve design is associated with increased reports of blood loss.
Product
Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-1210-2017·2017-02-22
Atrium Medical Recalls Maquet Express Dry Seal Suction OCEAN DRAIN Chest Drains
Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN chest drains because the manual vent valve may fail to re-seal after use.
Product
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1206-2017·2017-02-22
Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains
Atrium Medical Corporation is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after use.
Product
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1209-2017·2017-02-22
Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains
Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction chest drains because the manual vent valve may fail to re-seal after being depressed.
Product
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2017·2017-02-22
Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains
Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction Chest Drains because the manual vent valve may fail to re-seal after being depressed.
Product
Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collecti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1190-2017·2017-02-22
Greatbatch Recalls T5766 Offset Reamer Handles Due to Drive Chain Seizure
Greatbatch Medical is recalling 1,441 T5766 Offset Reamer Handles because the drive chain U-joints may seize during hip surgery, rendering the device non-functional.
Product
Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1144-2017·2017-02-15
Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings
Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.
Product
LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1142-2017·2017-02-15
Merge Healthcare Recalls Eye Station Imaging Devices Due to Capture Failures
Merge Healthcare is recalling 182 Eye Station capture stations because they may fail to capture eye images as intended, posing a risk to patient health.
Product
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2017·2017-02-08
Medtronic Strata II Valves Recalled for Pressure Discrepancies
Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.
Product
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2017·2017-01-18
Alcon Monarch III Cartridge Recalled Due to Potential Lens Lodging
Alcon Research, Ltd. is recalling 1,130 Monarch III (1) "C" Cartridges because the intraocular lens could become lodged within the device.
Product
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0941-2017·2017-01-11
Interventional Spine Recalls G3 Opticage Expandable Interbody Fusion Devices
Interventional Spine Inc is recalling 239 G3 Opticage Expandable Interbody Fusion Devices because the proximal end may separate during implantation, preventing the device from expanding.
Product
G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2017·2016-12-28
Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect
Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.
Product
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0900-2017·2016-12-28
Exactech Recalls Equinoxe Reverse Shoulder Screw Kits Due to Disengaged Heads
Exactech, Inc. is recalling 2,278 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kits because disengaged screw heads may not be retained in the screwdriver.
Product
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0892-2017·2016-12-28
Medtronic Recalls PowerCross .018 OTW PTA Dilatation Catheters
Medtronic is recalling 315 units of the PowerCross .018 OTW PTA Dilatation Catheter due to a manufacturing defect causing the balloon to fail to inflate or deflate properly.
Product
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0386-2017·2016-12-28
Teleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect
Teleflex Medical is recalling LMA MADdy topical anesthesia sprays because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0385-2017·2016-12-28
Teleflex Recalls LMA MADett Endotracheal Tubes for Inadequate Anesthesia Delivery
Teleflex Medical is recalling LMA MADett endotracheal tubes because they may fail to atomize medication, potentially causing inadequate anesthesia.
Product
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0381-2017·2016-12-28
Teleflex Recalls LMA MADomizer Sprays Due to Inadequate Atomization
Teleflex Medical is recalling LMA MADomizer devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.
Product
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a ful
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0700-2017·2016-12-14
Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation
Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.
Product
Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0714-2017·2016-12-14
Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error
Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.
Product
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technolo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0403-2017·2016-11-23
Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update
C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents to add a warning about potential knots during removal.
Product
Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0362-2017·2016-11-16
Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
Hospira is recalling Symbiq Two Channel Infusers that may display a white screen, causing the device to stop infusion and sound an alarm, which can delay or interrupt therapy.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritional
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2017·2016-11-16
Hospira Symbiq Infusion Pump Recalled for White Screen Shutdown
Hospira is recalling 10,337 Symbiq One Channel Infusers because a software issue may cause a white screen, stopping infusion and interrupting therapy.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritional
Category
Medical Device
Distribution
Distributed nationwide