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 26261–26280 of 38,428 recalls

September 16, 2016· GE Healthcare, LLC

Recalled Item: Brivo XR385

The Issue: The placing of weight on the VRAD detector,

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

Class II — Potential Health HazardTerminated
September 16, 2016· Ion Beam Applications S.A.

Recalled Item: Proteus ONE and Proteus Plus

The Issue: IBA is initiating this recall to notify its

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

Class II — Potential Health HazardTerminated
September 16, 2016· Ion Beam Applications S.A.

Recalled Item: 12C

The Issue: IBA is initiating this recall to notify its

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Becton Dickinson & Company

Recalled Item: BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G

The Issue: BD identified that several lots did not receive

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

Class II — Potential Health HazardTerminated
September 16, 2016· Natus Medical Incorporated

Recalled Item: Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy

The Issue: The firm sent the Technical Bulletin to consignees

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

Class II — Potential Health HazardTerminated
September 16, 2016· Randox Laboratories

Recalled Item: The Randox Liquid Cardiac Controls Level 1

The Issue: An internal real-time stability monitoring program revealed decreased

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

Class II — Potential Health HazardTerminated
September 16, 2016· Vascular Solutions, Inc.

Recalled Item: Vascular Solutions Twin-Pass .023" Dual Access Catheter

The Issue: Vascular Solutions is recalling Twin-Pass dual access catheters

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

Class I — Serious Health HazardTerminated
September 16, 2016· Vascular Solutions, Inc.

Recalled Item: Vascular Solutions Twin-Pass RX Dual Access Catheter

The Issue: Vascular Solutions is recalling Twin-Pass dual access catheters

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

Class I — Serious Health HazardTerminated
September 16, 2016· Vascular Solutions, Inc.

Recalled Item: Vascular Solutions Twin-Pass Dual Access Catheter

The Issue: Vascular Solutions is recalling Twin-Pass dual access catheters

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

Class I — Serious Health HazardTerminated
September 16, 2016· RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Recalled Item: RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod

The Issue: RTI Surgical Inc. (RTI) is conducting a voluntary

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

Class II — Potential Health HazardTerminated
September 15, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B)

The Issue: Siemens determined that discrepant low calcium recovery of

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

Class II — Potential Health HazardTerminated
September 15, 2016· Battle Creek Equipment Co.

Recalled Item: Model 055: Thermophore Classic

The Issue: Products manufactured with the SPT cord have a

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

Class II — Potential Health HazardTerminated
September 15, 2016· Keystone Dental Inc

Recalled Item: Keystone Dental PrimaConnex¿ Straight Implant TC

The Issue: Small diameter (SD) cover screw was packaged with

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

Class II — Potential Health HazardTerminated
September 15, 2016· SenTec AG

Recalled Item: SDMS (SenTec Digital Monitoring System)

The Issue: Sentec AG found that with one batch of

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

Class II — Potential Health HazardTerminated