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 27581–27600 of 38,428 recalls
Recalled Item: Dimension Vista 500 Intelligent Lab System running on software versions
The Issue: Discrepant patient results on Dimension Vista Intelligent Lab
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 1500 Intelligent Lab System running on software versions
The Issue: Discrepant patient results on Dimension Vista Intelligent Lab
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PC unit
The Issue: The Alaris PC units model 8015 may display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole
The Issue: The following issues are found in NeuViz 16
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Emerald Cleaner
The Issue: Three lots of CELL-DYN Emerald Cleaner may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nutrient Gelatin
The Issue: Incorrect expiration date was listed on the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novocastra Liquid Mouse Monoclonal Antibody Calretinin
The Issue: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Fetch 2 Aspiration Catheter
The Issue: Boston Scientific is recalling all models of Fetch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Self-Cath¿ Pediatric Catheter Size CH 06
The Issue: Coloplast Corp. is voluntarily recalling a single lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spetzler Claw Tip
The Issue: The Spetzler Claw Tip was packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS
The Issue: Siemens became aware that the front cover on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack Latex Free
The Issue: These packs contain item #4037 Kerlix X-ray Detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: General Surgery Pack
The Issue: These packs contain item #4037 Kerlix X-ray Detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack
The Issue: These packs contain item #4037 Kerlix X-ray Detectable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex MEDICAL AngioVac Circuit
The Issue: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioVac Circuit Pack (Tandem Packs)
The Issue: Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardy Diagnostics GBS Detect Cat no. A300. Used for the
The Issue: Performance failure; poor hemolytic reaction of non or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile
The Issue: The incorrect DFU was packaged with two lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GDC-18 360 11MM X 30CM Detachable Coil Sterile
The Issue: The incorrect DFU was packaged with two lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.