DeRoyal limb holders: — Class II medical device recall Z-1562-2022
Terminated recall by DeRoyal Industries Inc, reported 2022-08-31, distributed nationwide. The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and
| Recall number | Z-1562-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2022-07-15 |
| Classified | 2022-08-22 |
| Reported by FDA | 2022-08-31 |
| Terminated | 2024-08-06 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00749756780728, 00749756780735, 00749756837828, 00749756849234 |
| Lot numbers | 57285721, 57369651, 57372551, 57419195, 57420031, 57462151, 5746744, 57497652, 57501121 |
| Model numbers | M8124, M8125, M8136, M8137 |
| Expiration dates | 2032-05-22, 2032-06-06, 2032-06-13, 2032-06-14, 2032-06-20, 2032-06-27 |
Product
DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.
Reason for recall
The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.
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-1562-2022. 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.