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.

38,428 total recalls
0 this month

Showing 20961–20980 of 38,428 recalls

May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS TANDEM 5F DL BIOFLO PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Bio-Stable 5F SL-55CM IR-145 Kit Valved PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: CAN 5F SINGLE XCELA PICC

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: 5F DL BIOFLO PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS 5F DL BIOFLO PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS TANDEM 5F DL XPP

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: 5F DL BIOFLO PICC

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: CAN 5F DUAL XCELA PICC

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS TANDEM 5F DL XCELA PICC PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS 5F DL BIOFLO PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Xcela 5FDL-55cm Maximal Barrier Nursing Kit PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS 5F DL BIOFLO PASV

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: RS 5F DL BIOFLO PICC

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 10, 2018· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG

The Issue: A component of the kits might contain unsafe

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated