FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
- Recall number
- Z-1604-2020
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
- Status
- Terminated
- Initiated
- 2020-02-27
- Posted
- not on file
- Terminated
- 2022-05-10
- Reason
- One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
- Root cause
- Nonconforming Material/Component
- Action
- DeRoyal issued their recall on 2/27/2020 to the end user level by emailing its direct accounts and sales representatives. The customers were asked to identify the affected products, quarantine them, return the affected product and the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Distributors were asked to further notify their customers. They were asked to do this directly or to provide the recalling firm with a customer listing and the recalling firm would notify them.
- Quantity
- 94 pairs
- Distribution
- VA, CA, FL, AZ
- Lot, serial or model codes
- GTIN: 0749756946865 Lot Code: 50192186
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMQ
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28