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 16121–16140 of 38,428 recalls

December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM)

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Enzymatic Creatinine (EZCR) reagent

The Issue: There is a potential for falsely depressed creatinine

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture UD 3/0 30 P-14

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture UD 4/0 18 P-13

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24

The Issue: There is a potential for packaging integrity issues

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

Class II — Potential Health HazardTerminated
December 18, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent

The Issue: There is a potential for falsely depressed creatinine

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

Class II — Potential Health HazardTerminated
December 18, 2019· Covidien LLC

Recalled Item: Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21

The Issue: There is a potential for packaging integrity issues

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

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

Recalled Item:

The Issue: Additive and Arrest Agent Labels on the MPS

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

Class II — Potential Health HazardTerminated
December 17, 2019· Boston Scientific Corporation

Recalled Item: AMS 700 100 mL

The Issue: A labeling discrepancy incorrectly labeled AMS 700 100mL

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

Class II — Potential Health HazardTerminated
December 17, 2019· W L Gore & Associates, Inc.

Recalled Item: Conformable Thoracic Stent Graft

The Issue: The incorrect label was placed on both 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 Pick Needles-.D04 GTIN: 8719214221584

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 Blunt Needles with luer-lock connector-.D05 GTIN: 8719214221621

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 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ

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 VFI Cannula-.D03 GTIN: 8719214221423

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 VFI Cannula-.D03 GTIN: 8719214221447

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 Silicone Tipped Cannula-.D01 GTIN: 8719214221522

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