Class II — Potential Health Hazard

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

FMsealer Open Shears. Model FM3001 Recalled by Domain Surgical, Inc. Due to Domain Surgical, Inc. announces a voluntary field action...

Date: October 24, 2016
Company: Domain Surgical, 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 Domain Surgical, Inc. directly.

Affected Products

FMsealer Open Shears. Model FM3001

Quantity: 70 units US; 175 units OUS

Why Was This Recalled?

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Domain Surgical, Inc.

Domain Surgical, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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