Class II — DeRoyal Industries Inc
| Recalling firm | DEROYAL INDUSTRIES, INC. |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system. |
| Product | HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. |
| Quantity | 16 cases of 50 units (800 eaches) |
| Distribution | Distributed in the states of VA, AL, FL, and CA. |
| Initiated | 2015-10-14 |
| Classified | 2015-11-30 |
| Terminated | 2017-07-01 |
| Recall number | Z-0345-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — DeRoyal Industries Inc (Z-0345-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72454/
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