Class II — Potential Health Hazard

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

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM Recalled by Aesculap Implant Systems LLC Due to Needleholder incorrectly labeled as 200MM when the actual...

Date: September 25, 2019
Company: Aesculap Implant Systems 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 Aesculap Implant Systems LLC directly.

Affected Products

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle

Quantity: 7 pieces

Why Was This Recalled?

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

Where Was This Sold?

This product was distributed to 2 states: AK, TX

Affected (2 states)Not affected

About Aesculap Implant Systems LLC

Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.

Related Recalls

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