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.

1526–1550 of 1800

HighFDA (Devices)·Z-0436-2016·2015-12-30
Draeger Recalls Optional PS500 Power Supply Units for Ventilators
Draeger Medical is recalling 2,422 optional PS500 power supply units for Evita V500 and Babylog VN500 ventilators due to unexpectedly short battery run times.
Product
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0471-2016·2015-12-30
Biomet Black Mamba Suture Passer Recalled for Weld Defect
Biomet is recalling 50 Black Mamba Suture Passers because a weld defect may cause the instrument's jaw to fail to actuate properly.
Product
Black Mamba Suture Passer
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0437-2016·2015-12-23
Medtronic MiniMed 620G Insulin Pump Recall for Motor Malfunction
Medtronic is recalling 53 MiniMed 620G insulin pumps because a motor malfunction may stop insulin delivery. The issue involves a ball bearing assembly.
Product
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump sys
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0438-2016·2015-12-23
Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction
Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.
Product
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0402-2016·2015-12-16
Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect
Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.
Product
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0342-2016·2015-12-09
Medtronic InSync III Pacemaker Recall for Battery Impedance Issue
Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.
Product
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0355-2016·2015-12-09
Procedure Products Recalls Ultra Modified Seldinger Needles Due to Insertion Difficulty
Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.
Product
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stai
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0320-2016·2015-12-02
Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue
Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.
Product
Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneousl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0262-2016·2015-11-18
Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects
Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.
Product
Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2016·2015-11-11
Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues
Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.
Product
HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualifie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2016·2015-11-11
Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation
Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.
Product
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2016·2015-11-11
Pyng Medical Recalls Tourniquets Not Reset to Ready Position
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
Product
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2766-2015·2015-09-23
Boston Scientific Recalls WATCHMAN Access Sheath Due to Valve Cross-Thread Risk
Boston Scientific is recalling WATCHMAN Access System sheaths because the hemostasis valve may cross-thread if tightened with the dilator in place, potentially preventing the valve from sealing.
Product
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2784-2015·2015-09-23
St Jude Merlin@home Transmitter Recalled for Backup VVI Operation
St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.
Product
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2765-2015·2015-09-23
Boston Scientific WATCHMAN Device Field Correction for Hemostasis Valve Cross-Thread Risk
Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.
Product
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2776-2015·2015-09-23
Edwards Pressure Monitoring Kit Recalled for Flow Restriction Issues
Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.
Product
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2494-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2517-2015·2015-09-09
Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters
Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.
Product
KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airw
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2523-2015·2015-09-09
Halyard KimVent Pediatric Closed Suction System Thumb Valve Defect Recall
Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.
Product
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2496-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2504-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2480-2015·2015-09-09
Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk
Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
Product
COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2015·2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Product
KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Category
Medical Device
Distribution
Distributed nationwide