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 11801–11820 of 38,428 recalls

August 11, 2021· Hill-Rom, Inc.

Recalled Item: LikoStretch 1900 Model Number: 3156051 - The combination of this

The Issue: Stretch Leveller has the potential to lose the

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

Class II — Potential Health HazardOngoing
August 11, 2021· Hill-Rom, Inc.

Recalled Item: Stretch Leveller Model Number: 3156200 - The combination of this

The Issue: Stretch Leveller has the potential to lose the

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

Class II — Potential Health HazardOngoing
August 11, 2021· Hill-Rom, Inc.

Recalled Item: FlexoStretch Model Number: 3156057 - The combination of this products

The Issue: Stretch Leveller has the potential to lose the

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

Class II — Potential Health HazardOngoing
August 11, 2021· Hill-Rom, Inc.

Recalled Item: OctoStretch with Stretch Leveller - The combination of this products

The Issue: Stretch Leveller has the potential to lose the

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

Class II — Potential Health HazardOngoing
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Cypress Medical Products LLC

Recalled Item: McKesson Lap Sponge

The Issue: Manufacturer issued a recall due to an EO

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

Class II — Potential Health HazardTerminated
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems...

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 11, 2021· Philips North America Llc

Recalled Item: SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems

The Issue: When using manual mode, the tabletop may not

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

Class II — Potential Health HazardCompleted
August 10, 2021· ROi CPS LLC

Recalled Item: REGARD Vitrectomy Tray

The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due

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

Class II — Potential Health HazardTerminated
August 10, 2021· ROi CPS LLC

Recalled Item: REGARD Ear Tray

The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due

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

Class II — Potential Health HazardTerminated
August 10, 2021· ROi CPS LLC

Recalled Item: REGARD Basic Cataract tray

The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due

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

Class II — Potential Health HazardTerminated