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 27661–27680 of 38,428 recalls
Recalled Item: Xcela Hybrid PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela PICC with PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology
The Issue: PICC catheters that contain valve(s) manufactured prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is
The Issue: There is a potential for partial or complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood
The Issue: Specific CDI¿ Blood Parameter Monitoring System 500 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID
The Issue: There is a potential problem with the cuvette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special
The Issue: There is a potential problem with the cuvette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET
The Issue: There is a potential problem with the cuvette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2
The Issue: Integra's post QA release review of historical product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miltex Premium Grade Self-Lock Chisel Blade Handle
The Issue: One lot of self-lock chisel blade handles have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.