DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep — Class II medical device recall Z-0240-2016
Terminated recall by DeRoyal Industries Inc, reported 2015-11-18, distributed in AR, FL, MN, NJ, OH, OK, SC. Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-
| Recall number | Z-0240-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2015-08-31 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-04-12 |
| Distributed | AR, FL, MN, NJ, OH, OK, SC |
| Quantity | 355 units |
| Reason classes | sterility |
| Lot numbers | 2016-09EE, 38085071, 38198163, 38229177, 38245020, 38247391, 38276045, 38276230, 38317548, 38345071, 38345266 |
| Model numbers | 50-12160.17, 50-12602.09, 8630, 89-3101.04, 89-4561.11, 89-4562.12, 89-7744.03, 89-8194.02, 89-8381.01, 89-8439.01 |
Product
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;
Reason for recall
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
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-0240-2016. 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.