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 21021–21040 of 38,428 recalls

May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 36"(90CM) 4-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 30"(75CM) 8-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 24"(60CM) 7-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 4-36"(90CM) 4-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 4-36" (90CM) 3-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PRONOVA SUTURE BLUE 122CM M1.5

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 36"(90CM) 3-0 BLU

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 24"(60CM) 6-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 4"(10CM) 8-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 30"(75CM) 4-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE 30"(75CM) 6-0 BLUE

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Ethicon, Inc.

Recalled Item: PROLENE SUTURE BLUE 48" 4-0 D/A SH-1

The Issue: The needle associated with certain suture product codes

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

Class II — Potential Health HazardTerminated
May 7, 2018· Roche Diabetes Care, Inc.

Recalled Item: Accu-Chek Performa Test Strip

The Issue: The recalling firm has identified two lots of

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

Class II — Potential Health HazardTerminated
May 7, 2018· Roche Diabetes Care, Inc.

Recalled Item: Accu-Chek Aviva Plus Test Strip

The Issue: The recalling firm identified four US lots of

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

Class II — Potential Health HazardTerminated
May 7, 2018· Roche Diabetes Care, Inc.

Recalled Item: Accu-Chek Inform II Test Strip

The Issue: The recalling firm has identified two lots of

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

Class II — Potential Health HazardTerminated
May 7, 2018· WRP Asia Pacific Sdn Bhd

Recalled Item: AmerisourceBergen PF Latex SG (Surgical Glove)

The Issue: Some left-handed gloves contain powder. Powdered surgical gloves

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

Class II — Potential Health HazardTerminated
May 5, 2018· Ortho-Clinical Diagnostics

Recalled Item: VITROS Sodium Slides

The Issue: for positively biased results

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

Class II — Potential Health HazardTerminated