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 16141–16160 of 38,428 recalls

December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 20G VFI Cannula-.D03 GTIN: 8719214221485

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Arthrex, Inc.

Recalled Item: Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile...

The Issue: There is a potential for blockage of the

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 23G PFC Injection Needle- .D01 GTIN: 8719214221362

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 25G PFC Injection Needle-.D01 GTIN: 8719214221386

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 25G Pick Needles-.D04 GTIN: 8719214221607

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 25G Blunt Needles with luer-lock connector-.D05 GTIN:

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 27G VFI Cannula-.D03 GTIN: 8719214221461

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: (1) VitreQ 20G BF Blunt Needles-.D51 GTIN: 8719214221089 (2)

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 17, 2019· Vitreq Bv

Recalled Item: VitreQ 27G Blunt Needles with luer-lock connector-.D05 GTIN:8719214221669

The Issue: Microscopic tears of the sterile pouch may compromise

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

Class II — Potential Health HazardTerminated
December 16, 2019· Ortho Clinical Diagnostics Inc

Recalled Item: VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5

The Issue: for Negatively Biased Na+ Urine Results Using

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

Class II — Potential Health HazardTerminated
December 16, 2019· Nextremity Solutions

Recalled Item: Stratum Lapidus Plate - Small Rt

The Issue: The product contains a different plate than indicated

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

Class II — Potential Health HazardTerminated
December 16, 2019· Synthes, Inc.

Recalled Item: 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE

The Issue: There is a possibility that the inner cap

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

Class II — Potential Health HazardTerminated
December 16, 2019· Synthes, Inc.

Recalled Item: 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE

The Issue: There is a possibility that the inner cap

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

Class II — Potential Health HazardTerminated
December 16, 2019· Synthes, Inc.

Recalled Item: 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE

The Issue: There is a possibility that the inner cap

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

Class II — Potential Health HazardTerminated
December 16, 2019· Smith & Nephew, Inc.

Recalled Item: LEGION AP Cutting Block Size 4

The Issue: Multiple lots of LEGION AP Femoral Cutting Blocks

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

Class II — Potential Health HazardOngoing
December 16, 2019· Synthes, Inc.

Recalled Item: 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE

The Issue: There is a possibility that the inner cap

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

Class II — Potential Health HazardTerminated
December 16, 2019· Synthes, Inc.

Recalled Item: 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE

The Issue: There is a possibility that the inner cap

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

Class II — Potential Health HazardTerminated
December 16, 2019· GE Healthcare, LLC

Recalled Item: Centricity Universal Viewer 6.0

The Issue: Centricity Universal Viewer measurements saved into a DICOM

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

Class II — Potential Health HazardTerminated