DeRoyal Sterile Custom Kits containing Cardinal Health Gowns — Class II medical device recall Z-1419-2020
Terminated recall by Deroyal Industries, Inc. Lafollette, reported 2020-03-11, distributed in NJ, RI. Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown partic
| Recall number | Z-1419-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deroyal Industries, Inc. Lafollette, La Follette, TN, United States |
| Recall initiated | 2020-02-04 |
| Classified | 2020-02-28 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2021-04-01 |
| Distributed | NJ, RI |
| Quantity | 2,100 units |
| Reason classes | microbial contamination, specification failure |
| Lot numbers | 2708DJ1, 3008DJ1, 3008DSJ1, 4418GSJ, 49227281, 49520963 |
| Model numbers | 9541NA |
| Expiration dates | 2023-08-01, 2023-09-01 |
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
Reason for recall
Cardinal Health 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-1419-2020. 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.