Z-1210-2014Class II

DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017

Name: Z-1210-2014 DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017
Creator: DeRoyal Industries Inc
Published: 2014-02-21
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2014-02-21 / Terminated / root cause: packaging

FDA source

DeRoyal Industries Inc began a recall of DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented... on 2014-02-21. FDA classified it as Class II and gives the reason as "Moldy smell in product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1210-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-21
Posted: 2014-03-14
Terminated: 2015-05-08
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
Product code: FMQ Restraint, Protective
Reason for recall: Moldy smell in product
Root cause tag: packaging
FDA root cause: Packaging
Action: DeRoyal initiated an Urgent Voluntary Recall dated February 21, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. DeRoyal has asked that products be destroyed, and that notice of destruction be sent back. For questions contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.
Quantity in commerce: 8,962 pairs
Distribution: Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
Product codes and lots: lot numbers 1143442 and 1161762

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1210-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-14

Product code FMQ

K963476Class IDisposable Limb HolderDeroyal Industries, Inc. / cleared 1997-01-22

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)