DeRoyal Industries Inc: Medical Device Recall in 2022 - (Recall #: Z-1562-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF M8137.

Product Classification:

Class II

Date Initiated: July 15, 2022

Date Posted: August 31, 2022

Recall Number: Z-1562-2022

Event ID: 90629

Reason for Recall:

The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

Status: Terminated

Product Quantity: 36 eaches and 7 pairs

Code Information:

(1) M8124 - Lot 57372551 / exp 06/06/2032; Lot 57285721 / exp 05/22/2032; Lot 57369651 / exp 06/06/2032; Lot 57497652 / exp 6/27/2032; GTIN: 00749756780728; (2) M8125 - Lot 5746744 / exp 6/20/2032; Lot 57419195 / exp 6/13/2032; Lot 57420031 / exp 6/14/2032; GTIN: 00749756780735; (3) M8136 - Lot 57501121 / exp 6/27/2032; GTIN: 00749756837828; (4) M8137 - Lot 57462151 / exp 6/20/2032; GTIN: 00749756849234.

Distribution Pattern:

US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated