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 20881–20900 of 38,428 recalls

May 17, 2018· Arrow International Inc

Recalled Item: VPS Rhythm ECG Accessory Pack with Johans Adapter

The Issue: Product pouch label may not easily identify the

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: C4 is an in vitro diagnostic assay for the quantitative

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Immunoglobulin M is an in vitro diagnostic assay for the

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Apolipoprotein A1 is an in vitro diagnostic assay for the

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Immunoglobulin A is an in vitro diagnostic assay for the

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Immunoglobulin G is an in vitro diagnostic assay for the

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Apolipoprotein B is an in vitro diagnostic assay for the

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: Transferrin is an in vitro diagnostic assay for the quantitative

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: C3 is an in vitro diagnostic assay for the quantitative

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Abbott Laboratories, Inc

Recalled Item: The

The Issue: An update to the Reagents and Specimen Collection

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

Class II — Potential Health HazardTerminated
May 16, 2018· Ceterix Orthopedics, Inc.

Recalled Item: Ceterix Disposable Knot Pusher / Suture Cutter

The Issue: nonconforming blades may result in a higher

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

Class II — Potential Health HazardTerminated
May 16, 2018· Medtronic Inc.

Recalled Item: Contour Plus Link 2.4

The Issue: CONTOUR PLUS LINK 2.4 meter with an incorrect

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

Class II — Potential Health HazardTerminated
May 16, 2018· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System

The Issue: The solenoid plunger tip length is too short

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

Class III — Low RiskTerminated
May 16, 2018· Elekta, Inc.

Recalled Item: HexaPOD evo RT Couch Top (also known as HexaPOD evo Module)

The Issue: Upon completion of a 6D workflow, the HexaPOD

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

Class II — Potential Health HazardTerminated
May 16, 2018· Ion Beam Applications S.A.

Recalled Item: Proteus 235

The Issue: Correction vector confirmation message is lost if access

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

Class II — Potential Health HazardTerminated
May 16, 2018· Zimmer Biomet, Inc.

Recalled Item: G-PIN 2.8BL 3.2PL 98CM 2PK

The Issue: The firm is recalling various trauma guide wires

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

Class II — Potential Health HazardTerminated
May 16, 2018· Zimmer Biomet, Inc.

Recalled Item: G-PIN 2.8BL 3.2PL 98CM 2PK

The Issue: The firm is recalling various trauma guide wires

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

Class II — Potential Health HazardTerminated
May 16, 2018· Zimmer Biomet, Inc.

Recalled Item: 3.2MM X 560MM COCR THD TIP

The Issue: The firm is recalling various trauma guide wires

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

Class II — Potential Health HazardTerminated
May 16, 2018· Zimmer Biomet, Inc.

Recalled Item: BALL TIP GUIDE WIRE 3.2MMX55CM

The Issue: The firm is recalling various trauma guide wires

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

Class II — Potential Health HazardTerminated
May 16, 2018· Zimmer Biomet, Inc.

Recalled Item: RECON DRILL 6MM X 439MM

The Issue: The firm is recalling various trauma guide wires

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

Class II — Potential Health HazardTerminated