Class II — Potential Health Hazard

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

Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS Recalled by Aesculap, Inc. Due to Aesculap Inc. (AIC (USA)) has initiated a voluntary...

Date: June 13, 2014
Company: Aesculap, 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 Aesculap, Inc. directly.

Affected Products

Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures

Quantity: 11

Why Was This Recalled?

Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.

Where Was This Sold?

This product was distributed to 4 states: GA, IL, NY, RI

Affected (4 states)Not affected

About Aesculap, Inc.

Aesculap, Inc. has 22 total recalls tracked by RecallDetector.

Related Recalls

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