Class II — Potential Health Hazard

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

AAMI 3 ROYALSILK SURGGOWN BNS L Recalled by Cardinal Health Due to The gowns contain an unknown level of bioburden,...

Date: January 11, 2020
Company: Cardinal Health
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 Cardinal Health directly.

Affected Products

AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

Quantity: 7,659,634 total units

Why Was This Recalled?

The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

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