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 24001–24020 of 38,428 recalls

May 12, 2017· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product

The Issue: Combo Screw Driver (Product Code 288211) tip has

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

Class II — Potential Health HazardTerminated
May 12, 2017· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203

The Issue: Combo Screw Driver (Product Code 288211) tip has

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

Class II — Potential Health HazardTerminated
May 12, 2017· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code:

The Issue: Combo Screw Driver (Product Code 288211) tip has

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

Class II — Potential Health HazardTerminated
May 12, 2017· Mesa Laboratories, Inc.

Recalled Item: MesaLabs Conductivity Standard Solution

The Issue: Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due

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

Class II — Potential Health HazardTerminated
May 11, 2017· Becton Dickinson & Co.

Recalled Item: BD Phoenix PMIC-107

The Issue: BD has recently confirmed quality control failures, related

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: 1.5T Signa HDxt

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: 1.5T Signa HDx

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: SIGNA Creator

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Signa PET/MR (K163619

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· GE Medical Systems, LLC

Recalled Item: Brivo MR355

The Issue: incorrect wiring of the Uninterruptable Power Supply,

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

Class II — Potential Health HazardTerminated
May 11, 2017· Philips Electronics North America Corporation

Recalled Item: Philips DigitalDiagnost 3.1.x X-Ray System

The Issue: During recent evaluations of the Philips DigitalDiagnost 3.1.x,

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

Class II — Potential Health HazardTerminated
May 11, 2017· Teleflex Medical

Recalled Item: Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets...

The Issue: Product size listed on the labeling is incorrect

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

Class II — Potential Health HazardOngoing
May 11, 2017· Argon Medical Devices, Inc

Recalled Item: Clear Flashback Needle 7cm x 18G AMC/4

The Issue: Argon Medical has received a complaint from one

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

Class II — Potential Health HazardTerminated
May 11, 2017· Zimmer Gmbh

Recalled Item: Normed General Instruments 503004541: Werber Countersink Cannulated for...

The Issue: the devices used a different raw material to

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

Class II — Potential Health HazardTerminated
May 10, 2017· ConvaTec, Inc

Recalled Item: Oxygen Mask Recalled by ConvaTec, Inc Due to

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

Class II — Potential Health HazardTerminated
May 10, 2017· Medtronic Navigation, Inc.

Recalled Item: Install CD

The Issue: Software issue related to the StealthStation S7 system

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

Class II — Potential Health HazardTerminated