Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Curity Gauze Sponges Recalled by Covidien LLC Due to Compromised sterility due to breach of barrier

Date: March 3, 2016
Company: Covidien LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.

Affected Products

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

Quantity: 713600

Why Was This Recalled?

Compromised sterility due to breach of barrier

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Covidien LLC

Covidien LLC has 248 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report