DeRoyal — Class II medical device recall Z-0835-2014
Terminated recall by DeRoyal Industries Inc, reported 2014-02-05, distributed nationwide. The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the te
| Recall number | Z-0835-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, New Tazewell, TN, United States |
| Recall initiated | 2013-09-17 |
| Classified | 2014-01-27 |
| Reported by FDA | 2014-02-05 |
| Terminated | 2017-06-05 |
| Distributed | Nationwide (US) |
| Quantity | 121 units |
| Reason classes | temperature control |
| Lot numbers | 32871821, 32976471, 33105247 |
| Model numbers | T652NS |
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Reason for recall
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
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-0835-2014. 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.