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 18181–18200 of 38,428 recalls

April 15, 2019· Hitachi America, Ltd., Power Systems Division

Recalled Item: PROBEAT-V

The Issue: There is a potential for a discrepant target

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

Class II — Potential Health HazardTerminated
April 15, 2019· Med Tec Inc

Recalled Item: CIVCO Solstice(TM) SRS Immobilization System

The Issue: There is a potential for movement of the

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

Class II — Potential Health HazardTerminated
April 15, 2019· Abbott Gmbh & Co. KG

Recalled Item: Alinity c Cuvette Segments

The Issue: Individual cuvettes within the Alinity c Cuvette Segment

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

Class II — Potential Health HazardTerminated
April 12, 2019· Bard Peripheral Vascular Inc

Recalled Item: BD WAVELINQ 4F EndoAVF System

The Issue: The firm has become aware of a potential

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

Class II — Potential Health HazardTerminated
April 12, 2019· TIDI PRODUCTS

Recalled Item: Posey Connected Twice-As-Tough Cuffs

The Issue: Not meeting design specifications

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

Class II — Potential Health HazardTerminated
April 12, 2019· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen

The Issue: When unscrewing the green cap from the pen,

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

Class II — Potential Health HazardTerminated
April 12, 2019· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen

The Issue: When unscrewing the green cap from the pen,

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

Class II — Potential Health HazardTerminated
April 12, 2019· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen

The Issue: When unscrewing the green cap from the pen,

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

Class II — Potential Health HazardTerminated
April 12, 2019· Tecan US, Inc.

Recalled Item: Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks

The Issue: Gas springs not always replaced within the interval

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

Class II — Potential Health HazardTerminated
April 12, 2019· OMNIlife science Inc.

Recalled Item: OMNIBotics iBlock Cutting Guide

The Issue: The OMNIBotics iBlock Cutting Guide does not lock

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

Class II — Potential Health HazardTerminated
April 11, 2019· Intuitive Surgical Inc

Recalled Item: da Vinci X Surgical System

The Issue: Failure of Universal Surgical Manipulators due to a

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

Class II — Potential Health HazardTerminated
April 11, 2019· Intuitive Surgical Inc

Recalled Item: da Vinci Xi Surgical System

The Issue: Failure of Universal Surgical Manipulators due to a

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

Class II — Potential Health HazardTerminated
April 11, 2019· NxStage Medical, Inc.

Recalled Item: NxStage PureFlow B Solution

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
April 11, 2019· NxStage Medical, Inc.

Recalled Item: NxStage PureFlow B Solution

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Straight Intraluminal Staplers

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Straight Intraluminal Staplers

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Endoscopic Curved Intraluminal Stapler

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Endoscopic Curved Intraluminal Stapler

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Straight Intraluminal Staplers

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted
April 11, 2019· Ethicon Endo-Surgery Inc

Recalled Item: Curved Intraluminal Staplers

The Issue: The staplers may have an insufficient firing stroke

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

Class I — Serious Health HazardCompleted