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.
Showing 1461–1480 of 38,428 recalls
Recalled Item: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
The Issue: for barb non-engagement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe
The Issue: Reverse Shoulder humeral liners have an articular surface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartstring III Proximal Seal System
The Issue: Three failure modes have been identified: failure of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe
The Issue: Reverse Shoulder humeral liners have an articular surface
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartstring III Proximal Seal System
The Issue: Three failure modes have been identified: failure of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penner Pacific Bathing Spa
The Issue: The device does not bear a unique device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Radiology Solutions software version 14.2.2
The Issue: Due to software issue, radiology reports may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips CT systems labeled as the following: 1. Brilliance iCT
The Issue: The patient support table (couch) may descend unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips CT systems labeled as the following: 1. IQon Spectral CT
The Issue: The patient support table (couch) may descend unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips CT systems labeled as the following: 1. Big Bore RT
The Issue: The patient support table (couch) may descend unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil
The Issue: The patient support table (couch) may descend unexpectedly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.