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 16041–16060 of 38,428 recalls

December 27, 2019· Wright Medical Technology, Inc.

Recalled Item: WRIGHT EVOLVE Proline Head

The Issue: Two lots of EVOLVE Modular Radial Head could

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

Class II — Potential Health HazardTerminated
December 27, 2019· Cook Inc.

Recalled Item: Dawson-Mueller Drainage Catheter

The Issue: Specific lots of the Dawson-Mueller Drainage Catheter were

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

Class II — Potential Health HazardTerminated
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo Connect ENPlus Spike Set Anti-free Flow

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo 924 Safety Screw Spike Set

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo Epump Safety Screw Spike with Flush Bag

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo Joey Safety Screw Spike with Flush Bag

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo Joey Safety Screw Spike Set

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 26, 2019· Cardinal Health Inc.

Recalled Item: Kangaroo Epump Safety Screw Spike Set

The Issue: The feeding spike sets may leak at the

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: Prometra II 20mL Pump. Catalog No. 13827 The device is

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: Prometra Programmable 20mL Pump. Catalog No. 91827 The device is

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: US Clinical 20mL Programmable Pump. Catalog No. 01827 The device

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: Prometra Programmable 20mL Pump. Catalog No. 11827 The device is

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: Prometra II Programmable 20mL Pump. Catalog No. 93827 The device

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 24, 2019· Flowonix Medical Inc

Recalled Item: Prometra II 40mL Pump. Catalog No. 16827 The device is

The Issue: A pump alarm function anomaly in the pump

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

Class II — Potential Health HazardOngoing
December 23, 2019· Nikon Metrology

Recalled Item: Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225

The Issue: The manufacturer identified a risk that their products

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

Class II — Potential Health HazardTerminated
December 23, 2019· Carroll-Baccari, Inc.

Recalled Item: LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)

The Issue: Samples of 114gm tubes of Lemon Prep, collected

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

Class II — Potential Health HazardTerminated
December 23, 2019· Carroll-Baccari, Inc.

Recalled Item: Wave Prep Tubes (1710-03) and single use cups (17--00-24)

The Issue: Samples of 114gm tubes of Lemon Prep, collected

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

Class II — Potential Health HazardTerminated
December 23, 2019· Carroll-Baccari, Inc.

Recalled Item: PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)

The Issue: Samples of 114gm tubes of Lemon Prep, collected

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

Class II — Potential Health HazardTerminated
December 23, 2019· Carroll-Baccari, Inc.

Recalled Item: MVAP MEDICAL SUPPLIES INC

The Issue: Samples of 114gm tubes of Lemon Prep, collected

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

Class II — Potential Health HazardTerminated
December 23, 2019· Philips North America, LLC

Recalled Item: VesselNavigator application used with Philips Azurion (Azurion 7 Series)...

The Issue: Due to a software defect, when a digital

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

Class II — Potential Health HazardTerminated