DeRoyal — Class II medical device recall Z-1583-2018
Terminated recall by DeRoyal Industries Inc, reported 2018-05-09. Non-sterile product was packaged inside a case that was labeled as sterile.
| Recall number | Z-1583-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2018-04-23 |
| Classified | 2018-05-01 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-11-09 |
| Countries outside the US | BE, HN, NL |
| Quantity | 1,800 pencils |
| Reason classes | labeling, sterility |
| Lot numbers | 44210051 |
| Model numbers | 88-001502 |
Product
DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general surgical
Reason for recall
Non-sterile product was packaged inside a case that was labeled as sterile.
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-1583-2018. 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.