DeRoyal Industries Inc: Medical Device Recall in 2020 - (Recall #: Z-1604-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

Product Classification:

Class II

Date Initiated: February 27, 2020

Date Posted: April 8, 2020

Recall Number: Z-1604-2020

Event ID: 85102

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.

Status: Terminated

Product Quantity: 94 pairs

Code Information:

GTIN: 0749756946865 Lot Code: 50192186

Distribution Pattern:

VA, CA, FL, AZ

Voluntary or Mandated:

Voluntary: Firm initiated