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 29541–29560 of 38,428 recalls

July 21, 2015· Neuro Kinetics, Inc.

Recalled Item: Neuro Kinetics

The Issue: The devices that included the OVAR research test

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

Class II — Potential Health HazardTerminated
July 21, 2015· CareFusion 303, Inc.

Recalled Item: Alaris Syringe Pump

The Issue: Channel Error code is displayed on the PC

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

Class I — Serious Health HazardTerminated
July 20, 2015· Bard Access Systems

Recalled Item: Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

The Issue: Bard Access Systems is recalling marketing brochures for

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

Class II — Potential Health HazardTerminated
July 20, 2015· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Neptune 2 Waste Management System Docking Station (120V and 230V)

The Issue: The Fluid Coupling Sleeve, a component within the

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

Class II — Potential Health HazardTerminated
July 20, 2015· Trilliant Surgical Ltd.

Recalled Item: Concave Reamer Head

The Issue: The cannulation of the Concave and Convex Reamer

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

Class II — Potential Health HazardTerminated
July 20, 2015· Trilliant Surgical Ltd.

Recalled Item: Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE

The Issue: Sterilization tray lids for the Tiger and Tiger

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

Class II — Potential Health HazardTerminated
July 20, 2015· Trilliant Surgical Ltd.

Recalled Item: 3.0/4.0 Cannulated Drill Bit

The Issue: The cannulation of the 3.0/4.0 Cannulated Drill Bit

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

Class II — Potential Health HazardTerminated
July 20, 2015· Trilliant Surgical Ltd.

Recalled Item: 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0

The Issue: The cutting efficiency of the Countersinks was out

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

Class II — Potential Health HazardTerminated
July 20, 2015· TITAN SPINE, LLC

Recalled Item: Titan Spine Endoskeleton Locking Bone Screw Assembly

The Issue: Titan Spine is recalling specific Endoskeleton TCS Integrated

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

Class II — Potential Health HazardTerminated
July 19, 2015· Elcam Medical, Inc.

Recalled Item: Elcam Medical MANI 3G Plate BLS RAD B.BRAUN

The Issue: Punctured blister packages were detected during the packaging

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

Class II — Potential Health HazardTerminated
July 19, 2015· Elcam Medical, Inc.

Recalled Item: Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS)

The Issue: Punctured blister packages were detected during the packaging

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

Class II — Potential Health HazardTerminated
July 17, 2015· Microbiologics Inc

Recalled Item: LYFO Disk

The Issue: LYFO Disk Catalog #0983L is to contain Candida

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

Class III — Low RiskCompleted
July 17, 2015· GE Healthcare

Recalled Item: Lightspeed 16 CT

The Issue: for expulsion of the Power Supply on

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

Class II — Potential Health HazardTerminated
July 17, 2015· GE Healthcare

Recalled Item: PET Discovery LS

The Issue: for expulsion of the Power Supply on

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

Class II — Potential Health HazardTerminated
July 17, 2015· GE Healthcare

Recalled Item: PET Discovery ST 16

The Issue: for expulsion of the Power Supply on

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

Class II — Potential Health HazardTerminated
July 17, 2015· Beckman Coulter Inc.

Recalled Item: MicroScan LabPro Information Manager System

The Issue: The software incorrectly allows the operator to manually

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

Class II — Potential Health HazardTerminated
July 17, 2015· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent

The Issue: Three lots of CD56 PE Cy 7, Catalog

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

Class II — Potential Health HazardTerminated
July 17, 2015· Advanced Sterilization Products

Recalled Item: Wall Chart for STERRAD 100NX System

The Issue: Advanced Sterilization PRoducts (ASP) is recalling the Wall

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

Class II — Potential Health HazardTerminated
July 17, 2015· Medtronic Navigation, Inc.

Recalled Item: Medtronic Passive Biopsy Needle Kit

The Issue: The adhesive between the sphere assembly and the

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

Class II — Potential Health HazardTerminated
July 17, 2015· Medtronic Navigation, Inc.

Recalled Item: Medtronic Passive Biopsy Needle Kit

The Issue: The adhesive between the sphere assembly and the

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

Class II — Potential Health HazardTerminated