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 22581–22600 of 38,428 recalls

October 24, 2017· Arrow International Inc

Recalled Item: Large Volume Abdominal Paracentesis Kit

The Issue: Product packaging may not be completely sealed

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

Class II — Potential Health HazardTerminated
October 24, 2017· Arrow International Inc

Recalled Item: ArrowClarke" PleuraSeal¿ Thoracentesis Kit

The Issue: Product packaging may not be completely sealed

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

Class II — Potential Health HazardTerminated
October 24, 2017· Zimmer Biomet, Inc.

Recalled Item: Persona Partial Knee Spacer Blocks To assist in partial knee

The Issue: Zimmer Biomet is conducting a medical device recall

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

Class II — Potential Health HazardTerminated
October 24, 2017· Medtronic Minimally Invasive Therapies Group

Recalled Item: Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is

The Issue: Incorrect packaging. In one lot of Argyle Suction

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

Class II — Potential Health HazardTerminated
October 24, 2017· Medacta Usa Inc

Recalled Item: The GMK knee system: designed for cemented use in total

The Issue: Medacta has observed a worldwide occurrence rate of

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

Class II — Potential Health HazardTerminated
October 24, 2017· Radiometer America Inc

Recalled Item: ABL800 analyzer with FLEXQ module. Device intended for in vitro

The Issue: Due to misinterpretation of the barcode by the

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

Class II — Potential Health HazardTerminated
October 24, 2017· Smith & Nephew, Inc.

Recalled Item: smith&nephew TRIGEN INTERTAN 10S

The Issue: A single lot of INTERTAN 10S 10 MM

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

Class II — Potential Health HazardOngoing
October 24, 2017· Windstone Medical Packaging, Inc.

Recalled Item: AMS

The Issue: Custom surgical kits were manufactured with part #63310

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: MINI PLASTICS SET

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: SUTURE REMOVAL TRAY

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: NEONATAL IV ACCESS SET

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: GENERAL PURPOSE INSTRUMENT TRAY

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: LATEX FREE IV START SET

The Issue: Convenience Kit containing components to assist practitioner with

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: CATHETER SECUREMENT SYSTEM

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: CIRCUMCISION TRAY

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: NEONATAL IV START KIT

The Issue: Convenience Kit containing components to assist practitioner with

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: IV START KIT

The Issue: Convenience Kit containing components to assist practitioner with

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: INFANT IV SECUREMENT KIT

The Issue: Convenience Kit containing components to assist practitioner with

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: SorbaView Shield Dressing Change Tray

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated
October 23, 2017· Centurion Medical Products Corporation

Recalled Item: BLOOD DRAW KIT

The Issue: Convenience Kit contains a PVP Prep Pad, received

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

Class II — Potential Health HazardTerminated