DeRoyal — Class II medical device recall Z-1210-2014
Terminated recall by DeRoyal Industries Inc, reported 2014-03-26, distributed nationwide. Moldy smell in product
| Recall number | Z-1210-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2014-02-21 |
| Classified | 2014-03-14 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR |
| Quantity | 8,962 pairs |
| Lot numbers | 1143442, 1161762 |
| Model numbers | M2017 |
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
Reason for recall
Moldy smell in product
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1210-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.