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 15901–15920 of 38,428 recalls
Recalled Item: Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft
The Issue: Incorrect power of lenses than the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeAir Telescopic Smoke Evacuation Pencil
The Issue: Hairline fractures in a component could allow electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Telescopic Uncoated (Push Button)
The Issue: Hairline fractures in a component could allow electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Telescopic Smoke Evac Pencil
The Issue: Hairline fractures in a component could allow electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Reaction Ring Segment
The Issue: Some lots ending in "17", "18", "19", or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AAMI 3 ROYALSILK 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 NONREIN 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 NONRNF SURG GWN 2XL XLNG 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 FABRIC REINF SURG GOWN 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 NON-REINF SURG GOWN LG 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 NONREINF SURGICAL GOWN 4XL
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: ROYALSILK 3XLARGE/XLONG 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 3XLARGE/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 NON-REINF SURGICAL GOWN XL
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROYALSILK LARGE
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 SCRUB SURG GWN 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 XLARGE
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GOWN SURG LG W/TOWEL ST BACK
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 SURGICAL GOWN 3XL
The Issue: The gowns contain an unknown level of bioburden,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.