Class II — Potential Health Hazard

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

SmartGown Breathable Surgical Gowns with raglan sleeves X-large Recalled by Cardinal Health Due to Potential for open packaging seals compromising the sterility...

Date: November 2, 2021
Company: Cardinal Health
Status: Ongoing
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 Cardinal Health directly.

Affected Products

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

Quantity: 224,312 units

Why Was This Recalled?

Potential for open packaging seals compromising the sterility of the surgical gowns

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cardinal Health

Cardinal Health has 75 total recalls tracked by RecallDetector.

Related Recalls

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