Class II — Potential Health Hazard

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

Insorb Subcuticular Skin Stapler. INSORB staples are made from an Recalled by Incisive Surgical Inc Due to A previous Turkish distributor over-labeled a portion of...

Date: March 19, 2015
Company: Incisive 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 Incisive Surgical Inc directly.

Affected Products

Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.

Quantity: 210 cartons (containing 6 INSORB staplers per carton)

Why Was This Recalled?

A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.

Where Was This Sold?

International Distribution Only - Turkey.

About Incisive Surgical Inc

Incisive Surgical Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

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