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 26521–26540 of 38,428 recalls

August 4, 2016· Integra LifeSciences Corp. d.b.a. Integra Pain Management

Recalled Item: INTEGRA Spinal Tray

The Issue: Integra LifeSciences is recalling Spinal Trays, Cat No

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

Class II — Potential Health HazardTerminated
August 4, 2016· Toshiba American Medical Systems Inc

Recalled Item: Xario 100 Diagnostic Ultrasound System

The Issue: Toshiba American Medical Systems (TAMS) is recalling the

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

Class II — Potential Health HazardTerminated
August 3, 2016· C.R. Bard, Inc.

Recalled Item: BARD¿ 70cc Piston Syringe with Catheter Tip

The Issue: Package Defect: Products may be at risk for

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

Class II — Potential Health HazardTerminated
August 3, 2016· C.R. Bard, Inc.

Recalled Item: BARD¿ Irrigation

The Issue: Package Defect: Products may be at risk for

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

Class II — Potential Health HazardTerminated
August 3, 2016· C.R. Bard, Inc.

Recalled Item: BARD¿ Piston Syringe

The Issue: Package Defect: Products may be at risk for

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

Class II — Potential Health HazardTerminated
August 3, 2016· C.R. Bard, Inc.

Recalled Item: BARDIA¿ 60cc Piston Irrigation Syringe

The Issue: Package Defect: Products may be at risk for

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

Class II — Potential Health HazardTerminated
August 3, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.:

The Issue: Siemens Healthcare Diagnostics determined that the Dimension Vista

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

Class II — Potential Health HazardTerminated
August 3, 2016· LeMaitre Vascular, Inc.

Recalled Item: 1.5 mm HYDRO LeMaitre Valvulotome

The Issue: Wire which deploys the loop may be come

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

Class II — Potential Health HazardTerminated
August 3, 2016· LeMaitre Vascular, Inc.

Recalled Item: 1.5 mm HYDRO LeMaitre Valvulotome without LeMills

The Issue: Wire which deploys the loop may be come

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

Class II — Potential Health HazardTerminated
August 3, 2016· Medtronic Cardiovascular Surgery-the Heart Valve Division

Recalled Item: Medtronic EnVeo R Delivery Catheter System (DCS)

The Issue: for vascular trauma with the use of

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

Class II — Potential Health HazardTerminated
August 3, 2016· LeMaitre Vascular, Inc.

Recalled Item: 1.5 mm HYDRO LeMaitre Valvulotome

The Issue: Wire which deploys the loop may be come

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

Class II — Potential Health HazardTerminated
August 2, 2016· Greatbatch Medical

Recalled Item: Greatbatch

The Issue: On December 17, 2015, Greatbatch discovered that the

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

Class I — Serious Health HazardTerminated
August 2, 2016· Becton Dickinson & Company

Recalled Item: catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5

The Issue: A recall was initiated by Hospira, Inc. for

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

Class II — Potential Health HazardTerminated
August 2, 2016· Hologic, Inc

Recalled Item: SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.

The Issue: Tip Breakage at the glue joint between the

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

Class II — Potential Health HazardTerminated
August 2, 2016· Randox Laboratories Ltd.

Recalled Item: Randox Lipase (Colorimetric) Product Usage: A lipase test system is

The Issue: According to the firm carry over was observed

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

Class II — Potential Health HazardTerminated
August 2, 2016· Best Sanitizers Inc

Recalled Item: Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is

The Issue: Certain lots of the acid solution in Acecide-C

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

Class II — Potential Health HazardTerminated
August 2, 2016· Zimmer Biomet, Inc.

Recalled Item: Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin

The Issue: The G-PIN 2.8BL 3.2PL 60 CM 2PK is

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

Class II — Potential Health HazardTerminated
August 2, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo.Plaza VB 10 A

The Issue: Siemens is releasing a Customer Advisory Notice to

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

Class II — Potential Health HazardTerminated
August 2, 2016· Alere San Diego, Inc.

Recalled Item: LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535

The Issue: Incorrect expiration date on the magnetic strip that

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

Class III — Low RiskTerminated
August 2, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo Plaza picture archiving and communication system (PAC) (PACS) intended

The Issue: Siemens is releasing a Customer Advisory Notice to

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

Class II — Potential Health HazardTerminated