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 18981–19000 of 38,428 recalls

January 10, 2019· Ottobock Orthopedic Industrie

Recalled Item: 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively

The Issue: Some of the installed valve-inserts have a diameter

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

Class II — Potential Health HazardTerminated
January 10, 2019· Ottobock Orthopedic Industrie

Recalled Item: 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is

The Issue: Some of the installed valve-inserts have a diameter

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

Class II — Potential Health HazardTerminated
January 9, 2019· Karl Storz Endoscopy

Recalled Item: Insufflation tubing to be used with varies insufflator units.

The Issue: The sterile single-use tubing may contain higher ethylene

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

Class III — Low RiskTerminated
January 9, 2019· Implant Direct Sybron Manufacturing LLC

Recalled Item: SwishPlus Implant 5.7mmD x 8mmL

The Issue: Due to a complaint received and internal investigation

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

Class II — Potential Health HazardTerminated
January 9, 2019· ConvaTec, Inc

Recalled Item: Nelaton Urinary Catheter

The Issue: An internal assessment of packaging confirmed the potential

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

Class II — Potential Health HazardOngoing
January 9, 2019· ConvaTec, Inc

Recalled Item: Feeding Tube Metric

The Issue: An internal assessment of packaging confirmed the potential

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

Class II — Potential Health HazardOngoing
January 9, 2019· ConvaTec, Inc

Recalled Item: FilterFlow Suction Handle CH24

The Issue: An internal assessment of packaging confirmed the potential

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

Class II — Potential Health HazardOngoing
January 9, 2019· ConvaTec, Inc

Recalled Item: Forceps Blue

The Issue: An internal assessment of packaging confirmed the potential

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC70

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC50

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC20

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC30

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC30 w/o trolley Government Bundle

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC30 w/ trolley Government Bundle

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC70 w/trolley Government Bundle

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC70 w/o trolley Government Bundle

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· Philips North America, LLC

Recalled Item: PageWriter TC50 Government Bundle

The Issue: Philips PageWriter TC cardiograph batteries which have reached

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

Class II — Potential Health HazardOngoing
January 9, 2019· NEUSOFT MEDICAL SYSTEMS IMP & EX

Recalled Item: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04

The Issue: For surview scan length more than 500mm,if the

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

Class II — Potential Health HazardTerminated
January 8, 2019· GETINGE US SALES LLC

Recalled Item: Maquet XS Flat Screen Monitor Holder

The Issue: The affected flat screen monitor holders might not

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

Class II — Potential Health HazardTerminated
January 8, 2019· GETINGE US SALES LLC

Recalled Item: Maquet XS Flat Screen Monitor Holder

The Issue: The affected flat screen monitor holders might not

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

Class II — Potential Health HazardTerminated