DeRoyal Industries Inc DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
Brand
DeRoyal Industries Inc
Lot Codes / Batch Numbers
GTIN: 0749756946865 Lot Code: 50192186
Products Sold
GTIN: 0749756946865 Lot Code: 50192186
DeRoyal Industries Inc is recalling DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: due to One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, VA
Page updated: Jan 10, 2026