Class II — Potential Health Hazard

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

SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use Recalled by Allergen Medical Due to Product is dual packaged in an inner and...

Date: January 8, 2013
Company: Allergen Medical
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 Allergen Medical directly.

Affected Products

SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.

Quantity: 225 units (US) and 81 (Outside US)

Why Was This Recalled?

Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured

Where Was This Sold?

This product was distributed to 13 states: CA, FL, GA, MI, MN, NJ, NY, OH, OR, RI, TX, VA, WA

Affected (13 states)Not affected

About Allergen Medical

Allergen Medical has 1 total recall tracked by RecallDetector.

Related Recalls

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