CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Aami 3 Fabric Reinf Surg Gown XL Ns recalled by Cardinal Health
Cardinal Health is recalling Aami 3 Fabric Reinf Surg Gown XL Ns, 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
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-1017-2020
- 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
- Masks, Gloves & PPE
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 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
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.
Questions about this recall
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: 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
Where was it sold?
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.
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.
Other products in this recall event
38 other products · FDA event 84733This product is part of a recall event; the main page for the event is Aami 3 Nonrein Scrbnurgown Bns L recalled by Cardinal Health.
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