CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Aami 3 Non-reinf Surgical Gown Xxl recalled by Cardinal Health

Cardinal Health is recalling Aami 3 Non-reinf Surgical Gown Xxl, distributed nationwide in the US. The recall was initiated on 11 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled7,659,634 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1028-2020
FDA event ID: 84733
Recalling firm: Cardinal Health, Waukegan, IL
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2020
FDA classified: 5 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Surgical Instruments

Timeline

11 Jan 2020	Recall initiated by company
5 Feb 2020	Classified by FDA	+25 days
12 Feb 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Aami 3 Non-reinf Surgical Gown Xxl recalled?

Yes. Cardinal Health recalled Aami 3 Non-reinf Surgical Gown Xxl on 11 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1028-2020.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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