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.

1126–1150 of 1800

HighFDA (Devices)·Z-3263-2018·2018-10-03
Biomet Recalls HipLOC Hip Fracture Fixation System Plates
Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.
Product
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fix
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3264-2018·2018-10-03
Biomet Recalls HipLOC Hip Fracture Fixation System Plates
Biomet UK Ltd. is recalling 6 units of HipLOC System 140° Plates due to an undersized bore that prevents the lag screw from fitting through the barrel.
Product
HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3082-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 340 mm, Item Number: 814409340
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3144-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3134-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3153-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3170-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3087-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440
Category
Medical Device
Distribution
42 states
SevereFDA (Devices)·Z-3086-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect
Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3021-2018·2018-09-19
Cardiovascular Systems Recalls Orbital Atherectomy Saline Infusion Pumps
Cardiovascular Systems Inc is recalling 18 Orbital Atherectomy System Saline Infusion Pumps because they may switch to stand-by during use, requiring a reset to continue treatment.
Product
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication indepen
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3071-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-3131-2018·2018-09-19
Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect
Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.
Product
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 460 mm, Item Number: 814511460
Category
Medical Device
Distribution
42 states
HighFDA (Devices)·Z-2959-2018·2018-09-12
Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect
Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.
Product
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2941-2018·2018-09-05
MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2951-2018·2018-09-05
Haemonetics OrthoPAT Reservoirs Recalled Due to Missing Cannula
Haemonetics is recalling 348 OrthoPAT QuickConnect Reservoirs because a missing cannula prevents blood from being emptied and processed.
Product
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2932-2018·2018-09-05
MedComp Recalls Hemodialysis Catheter Kits Due to Suture Wing Cracking Risk
Medical Components, Inc. is recalling specific hemodialysis catheter insertion kits because suture wings may crack or break, posing a risk of patient injury.
Product
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2935-2018·2018-09-05
MedComp Recalls Duo-Flow IJ Full Trays Due to Suture Wing Cracking
Medical Components, Inc. is recalling Duo-Flow IJ Full Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
Product
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2950-2018·2018-09-05
Haemonetics OrthoPAT System-Integrated Set Recalled Due to Missing Cannula
Haemonetics is recalling OrthoPAT System-Integrated Sets because missing cannulas prevent blood from emptying, making the collected blood unusable.
Product
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2795-2018·2018-08-22
Hamilton-C1 Ventilator Recall Due to Control Board Component Defect
Hamilton Medical AG is recalling 16 Hamilton-C1 ventilators because a defective control board component may cause the device to shut down and trigger alarms.
Product
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2796-2018·2018-08-22
Hamilton-C3 Ventilator Recalled Due to Control Board Component Defect
Hamilton Medical AG is recalling two Hamilton-C3 ventilators because an out-of-specification control board component may cause the device to shut down and trigger alarms.
Product
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward,
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-2700-2018·2018-08-15
Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2713-2018·2018-08-15
Howmedica Recalls 546 Bipolar Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.
Product
#4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2569-2018·2018-08-08
Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect
Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.
Product
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2528-2018·2018-08-01
Medela Invia Motion Negative Pressure Wound Therapy System Recalled for Battery Error
Medela Inc is recalling 778 units of the Invia Motion Negative Pressure Wound Therapy System because the device may display a battery missing error.
Product
Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2431-2018·2018-07-25
Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect
Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.
Product
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurost
Category
Medical Device
Distribution
0 states