FDA Device recall Z-1024-2020

ROYALSILK 3XLARGE/XLONG, Gown

FDA Device
Class II
terminated
Published 2020-02-12

On 2020-02-12 the FDA classified a Class II recall of ROYALSILK 3XLARGE/XLONG, Gown by Cardinal Health, citing the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1024-2020
Classification	Class II
Status	terminated
Initiated	2020-01-11
Published	2020-02-12
Last updated	2026-09-13 11:55 UTC
Company	Cardinal Health
Distribution	US

Product

ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998

Reason

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

Identifiers

code_info	Lot Numbers: XXXXJXXX Single-Sterile Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19)… Lot Numbers: XXXXJXXX 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

code_info

Lot Numbers: XXXXJXXX Single-Sterile Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19)…

Lot Numbers: XXXXJXXX 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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1024-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.