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 25561–25580 of 38,428 recalls
Recalled Item: Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical 16400 Express Mini 500 dry seal drain Product
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sekisui Diagnostics Ammonia L3K¿ Assay
The Issue: Certain lots are showing an atypical decrease in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: symmetry surgical ULTRA(R) Steam container
The Issue: Sealant on the base trim of sterilizer container
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: symmetry surgical ULTRA(R) Gravity container
The Issue: Sealant on the base trim of sterilizer container
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: symmetry surgical ULTRA(R) Sterrad container
The Issue: Sealant on the base trim of sterilizer container
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes VA Implant Rack for the Compact Distal Radius System
The Issue: The screw rack plate was assembled incorrectly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XCELA PASV 5F DL 55CM MST-70 KIT PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XCELA PASV 5F DL 55CM IR-145 KIT PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F SL-55CM IR-145 Kit Valved PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela PICC Kit with ENDEXO and PASV Valve Technology
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM IR-145 Kit Valved PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG
The Issue: Navilyst Medical, Inc. (NMI) the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.