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 15201–15220 of 38,428 recalls

April 20, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The

The Issue: Main cable can be plugged or unplugged from

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

Class II — Potential Health HazardTerminated
April 20, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Cios Spin VA30-mobile X-Ray system

The Issue: Main cable can be plugged or unplugged from

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

Class II — Potential Health HazardTerminated
April 17, 2020· Alcon Research LLC

Recalled Item: Acrysof

The Issue: Incorrect IOL diopter

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

Class II — Potential Health HazardTerminated
April 17, 2020· Baxter Healthcare Corporation

Recalled Item: Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis

The Issue: disconnection of tubing set

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

Class II — Potential Health HazardTerminated
April 17, 2020· Baxter Healthcare Corporation

Recalled Item: Gambro Cartridge Blood Set Prime Line - Product Usage: is

The Issue: disconnection of tubing set

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

Class II — Potential Health HazardTerminated
April 17, 2020· Baxter Healthcare Corporation

Recalled Item: Gambro Cartridge Blood Transport System for Hemodialysis Blood Set -

The Issue: disconnection of tubing set

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

Class II — Potential Health HazardTerminated
April 17, 2020· Baxter Healthcare Corporation

Recalled Item: Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood

The Issue: disconnection of tubing set

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 154335 Oxford Partial Knee System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 184762 Knees Vanguard Knee System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: TMJPM-1510 Microfixation Custom Made Device

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 189260 Vanguard Knee System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Cios Spin Image-Intensified Fluoroscopic X-Ray System

The Issue: The unplugging of the main cable on the

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 183622 Vanguard Knee System PS Tibial Bearing

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 189420 Vanguard Knee System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Hip Products Item Number: 1) 110010462 RingLoc Hip System

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated
April 17, 2020· Biomet, Inc.

Recalled Item: Knee Products: 141356 Regenerex Series-A Patella 3 Peg

The Issue: presence of elevated endotoxin levels that exceed

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

Class II — Potential Health HazardTerminated