Z-1562-2022Class II

DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb...

Name: Z-1562-2022 DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb...
Creator: DeRoyal Industries Inc
Published: 2022-07-15
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2022-07-15 / Terminated

FDA source

DeRoyal Industries Inc began a recall of DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3)... on 2022-07-15. FDA classified it as Class II and gives the reason as "The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1562-2022
Classification: Class II
Status: Terminated
Initiated: 2022-07-15
Posted: 2022-08-22
Terminated: 2024-08-06
Recalling firm: DeRoyal Industries, Inc.
Product: 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 code: FMQ Restraint, Protective
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.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued recall letters dated 7/15/2022 via email to the distributors and sale representative, and via overnight mail to the institution on 7/15/2022. The letter with an attached Affected Products Listing explained the reason for recall, the health risk, and provided actions for the customer to take, which included the following: Using the attached Affected Products Listing, identify the affected part numbers and lot numbers in inventory and place them in quarantine pending return. Complete the Notice of Return Form and return it to the recalling firm via FAX or email no later than 8/26/2022. If the product has been further distributed, the customer is requested to contact their customers by either forwarding the recall notification or requesting the recalling firm notify them.
Quantity in commerce: 36 eaches and 7 pairs
Distribution: US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-31	2022-08-22

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)