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 30901–30920 of 38,428 recalls

March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices)...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices)...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT 64 channel with Essence

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices)...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed...

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory

The Issue: The firm was notified that the failure of

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

Class II — Potential Health HazardTerminated
March 6, 2015· Brainlab AG

Recalled Item: ExacTrac 6.x. is software used to place patients at an

The Issue: ExacTrac 6.x Patient Positioning System: Potentially incorrect patient

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

Class II — Potential Health HazardTerminated
March 6, 2015· Cyberonics, Inc

Recalled Item: VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse

The Issue: The pulse generators have a lower battery longevity

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

Class II — Potential Health HazardTerminated
March 6, 2015· Wright Medical Technology, Inc.

Recalled Item: CROSSCHECK(R) Plating system

The Issue: The minor diameter, major diameter, thread pitch, and

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

Class II — Potential Health HazardTerminated
March 6, 2015· Wright Medical Technology, Inc.

Recalled Item: CROSSCHECK(R) Plating system

The Issue: The minor diameter, major diameter, thread pitch, and

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

Class II — Potential Health HazardTerminated
March 6, 2015· Wright Medical Technology, Inc.

Recalled Item: CROSSCHECK(R) Plating system

The Issue: The minor diameter, major diameter, thread pitch, and

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

Class II — Potential Health HazardTerminated