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 15941–15960 of 38,428 recalls
Recalled Item: AAMI 3 NON-RNF SURG GOWN 3XL LONG
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AAMI 3 ROYALSILK SURGGOWN BNS 2XL
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AAMI 3 FABRNF SCRUB SURG GWN XL NS
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AAMI 3 FABREINF SURG GOWN LARGE
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-360 Automated Immunoassay Analyzer
The Issue: A display screen software issue on the analyzer
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 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 4.1MM(D) X 6MM(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: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(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 5MM(D) X 6MM(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: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(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 4.1MM(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: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(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: 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 5MM(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 3.4MM(D) X 3.8MM(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 4.1MM(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: CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(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 4.1MM(D) X 4.1MM(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 5.6MM(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 6MM(H)
The Issue: Resulting impression or scanned data produced from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.