Z-1604-2020Class II

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 -

Name: Z-1604-2020 DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 -
Creator: DeRoyal Industries Inc
Published: 2020-02-27
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2020-02-27 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint on 2020-02-27. FDA classified it as Class II and gives the reason as "One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1604-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-27
Posted: 2020-03-30
Terminated: 2022-05-10
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Product code: FMQ Restraint, Protective
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 94 pairs
Distribution: VA, CA, FL, AZ
Product codes and lots: GTIN: 0749756946865 Lot Code: 50192186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1604-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1604-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-30

Product code FMQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)