FDA Device recall Z-1604-2020
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint by Deroyal Industries, citing one lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1604-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-27 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Deroyal Industries |
| Distribution | AZ, CA, FL, VA |
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Reason
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Identifiers
| code_info | GTIN: 0749756946865 Lot Code: 50192186 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1604-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.