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 28181–28200 of 38,428 recalls

January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 32 consists of all product under product code: HWC

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 9 consists of all product under HRS

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 50 consists of all product under product code: JWH

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 39 consists of all product under product code: JDI

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 57 consists of all product code: JDI and same

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 11 consists of all product under product code JDI

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 33 consists of all product under product code: JDI

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 38 consists of all product under product code: HSB

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 58 consists of all product under product code: HRS

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 55 consists of all product under product code: HSB

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 6 consists of all products under product code HWC

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 2 consists of all products product code LPH

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 61 consists of all product under product code: JWH

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 68 consists of all product under product code: JDI

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 21 consists of all product under product code: JDI

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 23 consists of all product code: JDI and same

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 44 consists of all product under product code: HWC

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 24 consists of all product under product code: HRS

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Manufacturing B.V.

Recalled Item: Product 72 consists of all product code: JDI and same

The Issue: As a result of the insufficient sealer calibration

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

Class II — Potential Health HazardTerminated
January 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NexGen Knee CR Option Fem NexGen Knee CR Porous Fem

The Issue: LDPE bag containing the implant adheres to the

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

Class II — Potential Health HazardTerminated