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 15961–15980 of 38,428 recalls
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUCLISENS¿ Lysis Buffer
The Issue: Following a customer complaint about colored eluates, leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion Assembly Pump Guts
The Issue: These roller pumps were assembled with pump shafts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Roller Pump
The Issue: These roller pumps were assembled with pump shafts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion Assembly Pump Guts
The Issue: These roller pumps were assembled with pump shafts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Roller Pump
The Issue: These roller pumps were assembled with pump shafts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
The Issue: The products are being recalled due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
The Issue: The products are being recalled due to reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage:
The Issue: Two software issues (1) Using the override function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System
The Issue: Two software issues (1) Using the override function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage:
The Issue: Two software issues (1) Using the override function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is
The Issue: Two software issues (1) Using the override function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis POWERFLEX P3
The Issue: Cordis is recalling one (1) lot of POWERFLEX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.