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 23501–23520 of 38,428 recalls

June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom PACEMAKER TRAY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom PV MINOR PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Quidel Corporation

Recalled Item: InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION

The Issue: In-house testing revealed the presence of plastic spurs

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

Class II — Potential Health HazardTerminated
June 22, 2017· Medtronic Perfusion Systems

Recalled Item: DLP Pressure Disposable Pressure Display Sets Extends the pressure line

The Issue: Identification of small pinholes in a single packaging

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

Class II — Potential Health HazardTerminated
June 22, 2017· Medtronic Perfusion Systems

Recalled Item: DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia...

The Issue: Identification of small pinholes in a single packaging

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

Class II — Potential Health HazardTerminated
June 22, 2017· Medtronic Perfusion Systems

Recalled Item: DLP Cardioplegia Adapter with Pressure Port Provides access for a

The Issue: Identification of small pinholes in a single packaging

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

Class II — Potential Health HazardTerminated
June 22, 2017· Medtronic Perfusion Systems

Recalled Item: DLP Pressure Monitoring Extension Line Adapters Extends the pressure line

The Issue: Identification of small pinholes in a single packaging

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

Class II — Potential Health HazardTerminated
June 22, 2017· Medtronic Perfusion Systems

Recalled Item: DLP Extension Line Adapters 20 in length Used to extend

The Issue: Identification of small pinholes in a single packaging

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252.

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local...

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· B. Braun Medical, Inc.

Recalled Item: Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia

The Issue: B. Braun Medical Inc. (BBMI) initiated this recall

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

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw

The Issue: Devices are not consistent with Quality System Requirements

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

Class II — Potential Health HazardTerminated
June 21, 2017· Valorem Surgical LLC

Recalled Item: PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle

The Issue: Devices are not consistent with Quality System Requirements

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

Class II — Potential Health HazardTerminated