DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and… recallZ-1604-2020 · DeRoyal Industries Inc · initiated Feb 27, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1604-2020
- Status
- Terminated
- Initiated by the company
- Feb 27, 2020
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 94 pairs
- Product code
- FMQ
- Distribution
- VA, CA, FL, AZ
Product description
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Code information (models, lots, serial numbers)
GTIN: 0749756946865 Lot Code: 50192186
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal M8138Deroyal Industries, Inc. · Restraint, protective1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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