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 1981–2000 of 38,428 recalls
Recalled Item: Model SM-32HF-Batt
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number SM-40HF-B-D-C
The Issue: Sedecal sent an email to its consignees to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BostonSight SCLERAL Lens
The Issue: Select orders of lenses were manufactured with errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BostonSight PROSE Lens.
The Issue: Select orders of lenses were manufactured with errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Product Name: VITROS Chemistry Products
The Issue: Quality control (QC) drift when certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Product Name: VITROS Chemistry Products
The Issue: Quality control (QC) drift when certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CHE Slides
The Issue: Quality control (QC) drift when certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CHE Slides (Japan)
The Issue: Quality control (QC) drift when certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM
The Issue: for hole in the Tyvek layer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaCross Access Solution (VXSK)
The Issue: for hole in the Tyvek layer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaCross RF Wire (VXW). Indicated for creation of an atrial
The Issue: for hole in the Tyvek layer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS...
The Issue: for hole in the Tyvek layer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superion IDS Kit Superion Indirect Decompression System 8MM
The Issue: As a result of a comprehensive product performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Akreos
The Issue: An off-power error was identified, which resulted in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Manifold Kit:
The Issue: High pressure tubing may relax over time causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Tubing Kit:
The Issue: High pressure tubing may relax over time causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: High Pressure Tubing:
The Issue: High pressure tubing may relax over time causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Waste Management Kit:
The Issue: High pressure tubing may relax over time causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog
The Issue: Due to manufacturing error, Intraosseous device built-in stabilizer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog
The Issue: Due to manufacturing error, Intraosseous device built-in stabilizer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.