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 16061–16080 of 38,428 recalls

December 23, 2019· Jjgc Industria E Comercio De Materials Dentarios Sa

Recalled Item: Neodent Tapered Guided Surgery Drill

The Issue: The laser engraving of the product incorrectly identifies

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

Class II — Potential Health HazardTerminated
December 23, 2019· Zimmer Biomet, Inc.

Recalled Item: Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

The Issue: for the expiration date on the outer

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

Class II — Potential Health HazardTerminated
December 23, 2019· GE Healthcare, LLC

Recalled Item: SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage:

The Issue: It was identified that due to a potential

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

Class II — Potential Health HazardTerminated
December 23, 2019· GE Healthcare, LLC

Recalled Item: SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage:

The Issue: It was identified that due to a potential

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

Class II — Potential Health HazardTerminated
December 23, 2019· GE Healthcare, LLC

Recalled Item: SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage:

The Issue: It was identified that due to a potential

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

Class II — Potential Health HazardTerminated
December 23, 2019· GE Healthcare, LLC

Recalled Item: SIGNA Vibrant Nuclear Magnetic Resonance Imaging System

The Issue: It was identified that due to a potential

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

Class II — Potential Health HazardTerminated
December 20, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Lipase

The Issue: Firm has received customer complaints regarding failed calibrations

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: PICC Set- PR-35052-HPHNM

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow Central Venous Catheterization Kit ASK-04200-UPM

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow EPIDURAL CATHETERIZATION KIT JH-05500

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow EPIDURAL CATHETERIZATION KIT YC-02220

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: (1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2")

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated
December 20, 2019· Arrow International Inc

Recalled Item: Arrow EPIDURAL CATHETERIZATION KIT CK-02220

The Issue: Product lidstock contains the incorrect expiration date for

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

Class II — Potential Health HazardTerminated