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 35721–35740 of 38,428 recalls
Recalled Item: Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
The Issue: Siemens became aware of an unintended behavior when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InSpan Inserter
The Issue: for set screw to be come deformed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Air Dermatome II
The Issue: This removal is in response to complaints alleging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Zimmer Air Dermatome
The Issue: This removal is in response to complaints alleging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Air Dermatome II
The Issue: This removal is in response to complaints alleging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDITECH Bi-Directional interactive Communication Analyzer Interface
The Issue: Incorrect transmission of laboratory results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadSuite software. The firm name on the label is Merge Healthcare
The Issue: Multiple studies were missing at a customer location
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach MIA 16 (16cm Minimally Invasive Attachment)
The Issue: Product did not reach expected sterility assurance level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension(R) Chemistry Wash (RD701)
The Issue: Siemens Healthcare Diagnostics received complaints of Chemistry Wash
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAD Fluoro Uro Systems - Luminos dRF
The Issue: Siemens has discovered through product monitoring a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO¿ Assay Software (OAS) Server
The Issue: There is evidence that an electrical short within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) VITROS 5
The Issue: There is evidence that an electrical short within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System (product code 6802413) Product Usage: For
The Issue: There is evidence that an electrical short within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System (VITROS 5
The Issue: There is evidence that an electrical short within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For
The Issue: There is evidence that an electrical short within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci 5 mm Instrument Cannulae for use with the
The Issue: Intuitive Surgical is implementing a voluntary Field Action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code:
The Issue: Seals may disengage from the cannula which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.