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 18201–18220 of 38,428 recalls

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
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
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: 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
April 10, 2019· Uromedica Inc.

Recalled Item: ProACT Implantation Instrument Set

The Issue: issue with the manufacture and inspection of

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

Class II — Potential Health HazardTerminated
April 10, 2019· Stryker Neurovascular

Recalled Item: Stryker Neurovascular

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 10, 2019· Stryker Neurovascular

Recalled Item: Stryker Neurovascular

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 10, 2019· Becton Dickinson & Company

Recalled Item: MaxZero Extension Sets with Needle-less Connector

The Issue: BD has decided to initiate a voluntary recall

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

Class II — Potential Health HazardTerminated
April 9, 2019· QUIDEL CARDIOVASCULAR INC

Recalled Item: Quidel Triage TOX Drug Screen Control 1 Kit Box containing

The Issue: Due to an error in the programming of

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

Class II — Potential Health HazardTerminated
April 9, 2019· Abbott Laboratories

Recalled Item: ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact

The Issue: Devices were delivered without the required dry ice

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

Class III — Low RiskTerminated
April 9, 2019· Cook Inc.

Recalled Item: Thoracentesis Set

The Issue: Affected products may have been manufactured with the

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

Class II — Potential Health HazardTerminated
April 9, 2019· Cook Inc.

Recalled Item: Pericardiocentesis Catheter Tray

The Issue: Affected products may have been manufactured with the

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

Class II — Potential Health HazardTerminated
April 9, 2019· Cook Inc.

Recalled Item: Pericardiocentesis Catheter Set

The Issue: Affected products may have been manufactured with the

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

Class II — Potential Health HazardTerminated
April 9, 2019· Cook Inc.

Recalled Item: Pericardiocentesis Catheter Tray

The Issue: Affected products may have been manufactured with the

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

Class II — Potential Health HazardTerminated
April 9, 2019· Microbiologics Inc

Recalled Item: Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226

The Issue: Product with incorrect shelf life

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

Class II — Potential Health HazardOngoing
April 9, 2019· Microbiologics Inc

Recalled Item: Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI:

The Issue: Product with incorrect shelf life

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

Class II — Potential Health HazardOngoing
April 9, 2019· Abbott Laboratories

Recalled Item: ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact

The Issue: Devices were delivered without the required dry ice

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

Class III — Low RiskTerminated
April 9, 2019· Abbott Laboratories

Recalled Item: ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The

The Issue: Devices were delivered without the required dry ice

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

Class III — Low RiskTerminated