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 11441–11460 of 38,428 recalls
Recalled Item: RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartGown Breathable Surgical Gowns with raglan sleeves X-large
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RoyalSilk Non-Reinforced Surgical Gowns XXX-large
The Issue: for open packaging seals compromising the sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN /
The Issue: Due to an uptick of complaints associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hanger-Bar 2P 45cm
The Issue: The Hanger-Bar is being recalled due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hanger-Bar 2P 45cm
The Issue: The Hanger-Bar is being recalled due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE
The Issue: Testing vendor notified Smith & Nephew that previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE
The Issue: Testing vendor notified Smith & Nephew that previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE
The Issue: Testing vendor notified Smith & Nephew that previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE
The Issue: Testing vendor notified Smith & Nephew that previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in
The Issue: When calibrating using the standard provided in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diversatek Health
The Issue: M-Catch Retrieval Nets, Part Number 1175-01 / Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.