Class II — Potential Health Hazard

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

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2 Recalled by Steris Corporation Due to Product not approved for release for US distribution

Date: March 22, 2022
Company: Steris Corporation
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 Steris Corporation directly.

Affected Products

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

Quantity: 152 cases

Why Was This Recalled?

Product not approved for release for US distribution

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Steris Corporation

Steris Corporation has 109 total recalls tracked by RecallDetector.

Related Recalls

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