AAMI 3 NON-REINF SURG GOWN 2XL BNS — Class II medical device recall Z-1003-2020
Terminated recall by Cardinal Health, reported 2020-02-12, distributed nationwide. The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contam
| Recall number | Z-1003-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health, Waukegan, IL, United States |
| Recall initiated | 2020-01-11 |
| Classified | 2020-02-05 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2023-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, CO, CR, DO, IL, MX, OM, PA, PH, SA |
| Quantity | 7,659,634 units |
| Reason classes | microbial contamination, specification failure |
| Model numbers | 9575NB |
Product
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
Reason for recall
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1003-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.