DeRoyal SECURITY CUFFS — Class II medical device recall Z-1604-2020
Terminated recall by DeRoyal Industries Inc, reported 2020-04-08, distributed in AZ, CA, FL, VA. One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force
| Recall number | Z-1604-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2020-02-27 |
| Classified | 2020-03-30 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2022-05-10 |
| Distributed | AZ, CA, FL, VA |
| Quantity | 94 pairs |
| UPC / GTIN / UDI-DI | 00749756946865 |
| Lot numbers | 50192186 |
| Model numbers | M8138 |
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Reason for recall
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
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-1604-2020. 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.