CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
DeRoyal(R) Limb Holders, Cotton Adjustable, Universal recalled
DeRoyal Industries is recalling DeRoyal(R) Limb Holders, Cotton Adjustable, Universal, distributed nationwide in the US. The recall was initiated on 21 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1210-2014
- FDA event ID
- 67686
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2014
- FDA classified
- 14 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Feb 2014 | Recall initiated by company | |
| 14 Mar 2014 | Classified by FDA | +21 days |
| 26 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Moldy smell in product
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
Questions about this recall
Is DeRoyal(R) Limb Holders, Cotton Adjustable, Universal recalled?
Yes. DeRoyal Industries recalled DeRoyal(R) Limb Holders, Cotton Adjustable, Universal on 21 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1210-2014.
Why was it recalled?
Moldy smell in product
Which lots are affected?
lot numbers 1143442 and 1161762
Where was it sold?
Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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