Cardinal Health: Medical Device Recall in 2020 - (Recall #: Z-1011-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 11, 2020

Date Posted: February 12, 2020

Recall Number: Z-1011-2020

Event ID: 84733

Reason for Recall:

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

Status: Terminated

Product Quantity: 7,659,634 total units

Code Information:

Lot Numbers: XXXXXJ or XXXXXJX Single-Sterile Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19) M Month in alpha code " If made in 2018 o J for September o K for October o L for November OR o M for December " If made in 2019, any value is affected R Product revision or suffix P Facility code is letter J XXX Sequential Number - Monthly reset OR Bulk Non-Sterile Lot Format: XXXYRPQ Where: XXX Elapsed days of year " " If made in 2018, 244 or greater is affected OR " " If made in 2019, any value is affected; see below for year made identifier Y Last character of year gown was made (2018 or 2019) R Product Revision P Facility code is letter J Q Plant shift identifier; this identifier was added during the affected time period and therefore older product may not contain this digit in the lot number

Distribution Pattern:

Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated