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 36221–36240 of 38,428 recalls

February 20, 2013· Orthopedic Alliance LLC

Recalled Item: Co-Cr cancellous bone screw

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Spinal Solutions, LLC

Recalled Item: Copperhead IBFD

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Spinal Solutions, LLC

Recalled Item: 40 mm Rod

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Spinal Solutions, LLC

Recalled Item: 50 mm Rod

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Spinal Solutions, LLC

Recalled Item: 50 mm Screw

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Orthopedic Alliance LLC

Recalled Item: Femoral head

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Orthopedic Alliance LLC

Recalled Item: Femoral component

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Spinal Solutions, LLC

Recalled Item: 60 mm Rod

The Issue: The recall of the Loaner Bin and Sterilization

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

Class II — Potential Health HazardTerminated
February 20, 2013· Genesys Orthopedic Systems, LLC

Recalled Item: 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys

The Issue: Manufacturing residue may be present on the cervical

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

Class II — Potential Health HazardTerminated
February 19, 2013· Hospira Inc.

Recalled Item: Minibore Extension Set

The Issue: Hospira, Inc. is voluntarily recalling one lot of

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

Class II — Potential Health HazardTerminated
February 19, 2013· Trumpf Medical Systems, Inc.

Recalled Item: Helion S Exam Light or H300 The device is intended

The Issue: fatigue failure of the plastic joint may

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

Class II — Potential Health HazardTerminated
February 19, 2013· Remel Inc

Recalled Item: Remel X/pect Flu A&B Control Swabs

The Issue: Flu A+ Control Swabs incorrectly give Flu A-

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

Class III — Low RiskTerminated
February 19, 2013· Tecan US, Inc.

Recalled Item: Tecan Freedom EVO with Touch Tools Suite Version 3.0 The

The Issue: WIth TouchTools 3.0 after the execution of a

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

Class II — Potential Health HazardTerminated
February 19, 2013· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic DPL Single Stage Venous Cannula with Metal Tip

The Issue: for uncharacteristically rough metal edges to occur

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

Class II — Potential Health HazardTerminated
February 18, 2013· Ge Medical Systems Information T

Recalled Item: Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging

The Issue: It was reported from a complaint that study

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

Class II — Potential Health HazardTerminated
February 18, 2013· Ge Healthcare It

Recalled Item: Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update

The Issue: A software defect was discovered that causes images

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

Class II — Potential Health HazardTerminated
February 18, 2013· GE Healthcare

Recalled Item: The Centricity PACS Workstation is intended for use as a

The Issue: Using Merge Exam in single Study Mode may

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

Class II — Potential Health HazardTerminated
February 18, 2013· MEDICAMAT S.A.

Recalled Item: Punch Hair Matic A surgical hair transplant device designed for

The Issue: Medicamat is initiating a field correction due to

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

Class II — Potential Health HazardTerminated
February 18, 2013· Biomerieux Inc

Recalled Item: VITEK 2 60 computer system when equipped with the following

The Issue: There is a potential to link an isolate

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

Class II — Potential Health HazardTerminated
February 18, 2013· Biomerieux Inc

Recalled Item: VITEK 2 XL computer system when equipped with the following

The Issue: There is a potential to link an isolate

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

Class II — Potential Health HazardTerminated