Hazard

Device Failure recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device failure 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.

176–200 of 240

HighFDA (Devices)·Z-0423-2023·2022-12-14
Omnipod 5 Controller charging port melting poses minor burn risk
Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.
Product
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0146-2023·2022-11-09
Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration
Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.
Product
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2023·2022-11-09
BD Nexiva IV Catheter May Leave Needle Tip Exposed During Withdrawal
The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.
Product
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0169-2023·2022-11-09
Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination
Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.
Product
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2023·2022-10-26
ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
Product
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2023·2022-10-26
IV Extension Sets Recalled for Bonded Joint Failure and Leakage Risk
B. Braun extension sets (Product Code 470169) are recalled due to high probability of bonded joint failure, which may cause leakage or detachment during use, risking bloodstream infections and medication exposure.
Product
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2022·2022-10-05
Medline ClearPro Trach T-Piece Suction Catheter May Separate at Connector
Medline is recalling 136,080 ClearPro Trach T-Piece Closed Suction Catheters because the suction catheter can come apart from the connector during patient suctioning.
Product
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1667-2022·2022-09-07
Hip Implant Stem Recalled for Failed Fatigue Testing
Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.
Product
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1561-2022·2022-08-31
Diaphragm pacing system external pulse generator recalled for circuit board defect
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1481-2022·2022-08-10
Endoscopic Grasper Instruments Recalled Due to Weld Separation Risk
Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.
Product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2022·2022-05-25
NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component
Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.
Product
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0908-2022·2022-04-27
Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk
Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.
Product
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2022·2022-04-27
Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date
Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.
Product
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0917-2022·2022-04-20
FDA Recalls Touch Screen Modules for IVUS Imaging Systems
Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.
Product
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
Category
Medical Device
Distribution
50 states
SevereFDA (Devices)·Z-0625-2022·2022-02-23
Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use
Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.
Product
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of nati
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0628-2022·2022-02-23
Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use
Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.
Product
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2022·2022-02-02
GE Vscan Extend Ultrasound Device May Fail to Power On
GE Vscan Extend portable ultrasound devices may not power on due to battery depletion caused by improper device handling. The device must be properly turned off before removing the battery or disconnecting from power sources.
Product
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-0464-2022·2022-01-12
Medtronic Abre Venous Stent System recalled for reports of stent migration
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2022·2022-01-05
Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0394-2022·2021-12-29
WIRION Embolic Protection System Filter Withdrawal Difficulties
Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.
Product
WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0351-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.
Product
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0346-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0350-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
Product
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0352-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Category
Medical Device
Distribution
Distributed nationwide