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 14081–14100 of 38,428 recalls
Recalled Item: Niobe ES System
The Issue: There is a potential for fire in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI)
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI)
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI)
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI)
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 -
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number:
The Issue: Incorrectly Labeled 'general medical device,' printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5.5MM Arthrogarde Hip Access Cannula
The Issue: The J Lock feature on the cannula body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution Apex
The Issue: There is a potential for a smudge artifact
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray
The Issue: malfunction in which the examination room monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo XP ProVue Retriever
The Issue: Increase in fracture complaints of the flexible, tapered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.