Class II — Potential Health Hazard

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

Retractor System Elastic Stays (Part 3314-lG Recalled by CooperSurgical, Inc. Due to There is a possibility that the seal of...

Date: September 4, 2018
Company: CooperSurgical, Inc.
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 CooperSurgical, Inc. directly.

Affected Products

Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

Quantity: 18,000 units

Why Was This Recalled?

There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CooperSurgical, Inc.

CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.

Related Recalls

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