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.

776–800 of 1800

HighFDA (Devices)·Z-0213-2022·2021-11-17
Philips Azurion X-Ray Systems may lock up during simultaneous button presses
Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.
Product
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2022·2021-11-10
FDA Recalls 3M Red Dot ECG Monitoring Electrodes Due to Potential Carbon Stud Breakage
3M Red Dot ECG monitoring electrodes (Catalog No. 2244) are being recalled due to potential breakage of the carbon stud from the eyelet. Approximately 2,081,000 units distributed nationwide and internationally are affected.
Product
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2022·2021-10-27
CADD Administration Sets with Incorrect Air Filter Assembly
Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.
Product
CADD Administration Sets, Model #21-7346-24
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0131-2022·2021-10-27
IUD Insertion Kit Recalled Over Manufacturing Standards Verification Issues
Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.
Product
Standard IUD Insertion Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0109-2022·2021-10-20
Babylog VN500 Ventilator Firmware Defect May Cause Brief Ventilation Interruption
A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.
Product
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0115-2022·2021-10-20
Elekta Medical Linear Accelerator Diode Failure Risk During Maintenance
Elekta medical linear accelerators may have a defective diode that could fail destructively when removed, with risk of ejected debris. No injuries have been reported.
Product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0111-2022·2021-10-20
Flower Drill Bit Kit missing AO connect feature may delay procedures
Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.
Product
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0011-2022·2021-10-13
ELI 280 Resting Electrocardiographs Recalled Due to Device Malfunction
Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.
Product
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0057-2022·2021-10-13
ZOLL ICY Intravascular Catheter Kit Recalled for Potential Catheter and Tubing Leaks
ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.
Product
Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0054-2022·2021-10-13
Zoll COOLINE Intravascular Catheter Kit recalled for potential leak hazard
ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.
Product
Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0065-2022·2021-10-13
ZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks
ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.
Product
Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2021·2021-10-06
Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2615-2021·2021-10-06
Cardiosave Hybrid IABP may unexpectedly shut down on AC power
The Cardiosave Hybrid Intra-Aortic Balloon Pump may unexpectedly shut down when running on AC power with one battery installed and the battery removed during charging. No injuries have been reported.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2578-2021·2021-10-06
Aesculap PAS-PORT Surgical Implant Recalled for Deployment Failure
Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.
Product
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2021·2021-10-06
Stretch Leveller Model 3156200 May Lose Horizontal Position Control
Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from the lift sheet.
Product
Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2504-2021·2021-09-29
DLP Left Heart Vent Catheters recalled due to potential wire protrusion
Medtronic is recalling 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
Product
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2509-2021·2021-09-29
Univation X knee implant devices recalled for potential loosening
Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.
Product
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2484-2021·2021-09-29
Philips Affiniti Ultrasound Systems Recalled for Software Lock-Up During Exams
Philips Ultrasound is recalling Affiniti diagnostic ultrasound systems due to a software defect that intermittently causes device lock-ups when exiting Review Mode during patient exams. No illnesses or injuries have been reported.
Product
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2475-2021·2021-09-22
Philips Allura Xper Imaging System Overheating and Malfunction Recall
Philips Allura Xper imaging systems may fail early when supplied with 480V, causing coil overheating and burning smell. When the system fails, X-ray imaging capability is reduced to emergency mode only.
Product
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2402-2021·2021-09-15
Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Product
Pipeline Flex Embolization Device
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-2411-2021·2021-09-15
MRI diagnostic device tabletop may not move completely in manual mode
Philips Ingenia 1.5T MRI systems may have a mechanical defect where the tabletop fails to move fully in and out during manual operation, potentially delaying patient evacuation and treatment.
Product
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2435-2021·2021-09-15
Nihon Kohden NKV-550 Ventilator Recalled for Defective Pressure Regulator
Nihon Kohden NKV-550 Ventilators with certain serial numbers have a defective gas inlet pressure regulator that could cause malfunction or device check failure. The recall affects 1,999 units distributed globally.
Product
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2437-2021·2021-09-15
Solero MTA Generator Requires Software Upgrade to Reduce Startup Error
Angiodynamics is servicing specific Solero MTA Generator units to upgrade the software and reduce Error 0001 during startup. Affected units are identified by serial number.
Product
Solero Generator US PG, Item No. H78712740000US0, Catalog No. 12740000US
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2285-2021·2021-09-01
Monoject Sodium Chloride Flush Syringes Recalled for Air Embolism Risk
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2284-2021·2021-09-01
Monoject flush syringe recall: plunger may reintroduce air into IV lines
Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.
Product
Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.
Category
Medical Device
Distribution
Distributed nationwide