DeRoyal Ultra/Mammo Tray — Class II medical device recall Z-0879-2022
Terminated recall by DeRoyal Industries Inc, reported 2022-04-13, distributed in FL, NJ, TN. A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manu
| Recall number | Z-0879-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2022-03-03 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2022-09-15 |
| Distributed | FL, NJ, TN |
| Quantity | 780 kits |
| UPC / GTIN / UDI-DI | 00749756623599 |
| Lot numbers | 53334442, 53815781, 54685720, 55247529, 55967067 |
| Model numbers | 89-4990.06 |
| Expiration dates | 2021-05-01, 2022-06-01, 2023-03-01, 2023-04-01 |
Product
DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Reason for recall
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
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-0879-2022. 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.