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 15921–15940 of 38,428 recalls
Recalled Item: AAMI 3 NON-REINF SURG GWN XL 2 TWL
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 L
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 SCRBNURGOWN BNS XL
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 NONREINF SURG GOWN 3XL BNS
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 SURG GOWN L 2 TOWELS
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 NONREIN SURG GOWN L BNS
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 NON-REINF SURG GOWN 2XL BNS
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 SURG GWN XL 2 TOWELS
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 NON-REINF SURGICAL GOWN XXL
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 NONREIN SCRBNURGOWN BNS XL
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 FABRIC REINF SURG GOWN 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 FABRNF SURGGWN XL LONG 2 TWL
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 L NS
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROYALSILK 2XLARGE
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 NON-REINF SURG GWN 3XL XLONG
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 SCRBNURGOWN BNS L
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 FABRIC REINFORCEDGown 2XL 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 NONREINF SURG GOWN 2XL XLONG
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 NONREIN SURGGOWN BNS XL
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 FABRIC REINF SURG GOWN 2XL
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.