Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 11281–11300 of 38,428 recalls

December 10, 2021· Mallinckrodt Pharmaceuticals Ireland Ltd

Recalled Item: THERAKOS CELLEX Photopheresis Procedural Kit

The Issue: This recall was initiated to recover a Dunnage

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· DIXI MEDICAL USA

Recalled Item: The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or

The Issue: deformation of the internal packaging (blister pack)

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· Greiner Bio-One North America, Inc.

Recalled Item: greiner bio-one VACUETTE TUBE

The Issue: Some of the blood collection tubes show clotting

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 9, 2021· Getinge Usa Sales Inc

Recalled Item: Vaporizer Sevoflurane Maquet Filling

The Issue: A potential chemical degradation of Sevoflurane by Lewis

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
December 9, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray

The Issue: safety issue under specific preconditons that may

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 8, 2021· Beckman Coulter Inc.

Recalled Item: AU/DxC AU Magnesium

The Issue: Lipemic interference for the Magnesium serum application failed

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 8, 2021· R82 A/S

Recalled Item: R82 by ETAC Push Brace for High-Low

The Issue: The chrome surface of the push brace can

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 8, 2021· Technomed Europe

Recalled Item: Disposable Subdermal Needle Electrode

The Issue: There is a high risk of the blue

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 7, 2021· Fresenius Medical Care Holdings, Inc.

Recalled Item: Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)-

The Issue: Error messages 206 (yellow) and 208 (red) technical

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
December 7, 2021· DePuy Orthopaedics, Inc.

Recalled Item: GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

The Issue: Stems may have an undersized spigot bore diameter

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 7, 2021· DePuy Orthopaedics, Inc.

Recalled Item: GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

The Issue: Stems may have an undersized spigot bore diameter

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
December 7, 2021· DePuy Orthopaedics, Inc.

Recalled Item: GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

The Issue: Stems may have an undersized spigot bore diameter

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated