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 27861–27880 of 38,428 recalls

February 17, 2016· Medical Depot Inc.

Recalled Item: Direct Supply aluminum crutch

The Issue: Tip crutch failure involving the bottom of the

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

Class II — Potential Health HazardTerminated
February 17, 2016· Medical Depot Inc.

Recalled Item: Universal aluminum crutch

The Issue: Tip crutch failure involving the bottom of the

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

Class II — Potential Health HazardTerminated
February 17, 2016· Medical Depot Inc.

Recalled Item: Universal Quick Adjust under the following labels: 1) Aluminum crutch

The Issue: Tip crutch failure involving the bottom of the

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

Class II — Potential Health HazardTerminated
February 17, 2016· Medical Depot Inc.

Recalled Item: Aluminum crutch under the following labels: 1) Aluminum crutch

The Issue: Tip crutch failure involving the bottom of the

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

Class II — Potential Health HazardTerminated
February 17, 2016· Medical Depot Inc.

Recalled Item: EZ adjust aluminum crutch under the following labels: 1) EZ

The Issue: Tip crutch failure involving the bottom of the

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

Class II — Potential Health HazardTerminated
February 17, 2016· Applied Medical Technology Inc

Recalled Item: Wilson Penile Implantation System Retractor Frame

The Issue: The firm received a complaint of an open

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

Class II — Potential Health HazardTerminated
February 17, 2016· Applied Medical Technology Inc

Recalled Item: TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA)

The Issue: The firm received a complaint of an open

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

Class II — Potential Health HazardTerminated
February 17, 2016· Applied Medical Technology Inc

Recalled Item: Wilson Implantation System Product Usage: Indicated to aid in tissue

The Issue: The firm received a complaint of an open

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

Class II — Potential Health HazardTerminated
February 17, 2016· Applied Medical Technology Inc

Recalled Item: TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS

The Issue: The firm received a complaint of an open

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

Class II — Potential Health HazardTerminated
February 17, 2016· Acorn Stairlifts Inc

Recalled Item: Acorn 180 Curved Stairlift

The Issue: Aluminum rivets holding the base squab to the

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

Class II — Potential Health HazardTerminated
February 17, 2016· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
February 17, 2016· GE Medical Systems, LLC

Recalled Item: GE Healthcare

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
February 17, 2016· Argon Medical Devices, Inc

Recalled Item: ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF

The Issue: The incorrect sheath was assembled to the device

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 4.5 mm Cannulated Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 4.5 mm Cortex Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 6.5 mm Cannulated Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 7.0 mm and 7.3 mm Cannulated Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 6.5 mm Cancellous Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 3.5 mm and 4.0 mm Cannulated Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated
February 16, 2016· Synthes (USA) Products LLC

Recalled Item: 4.0 mm Cortex Screw

The Issue: Labeling does not match the cleared indications for

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

Class II — Potential Health HazardTerminated