FDA Device recall Z-0345-2016
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only by Deroyal Industries, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0345-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-14 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Deroyal Industries |
| Distribution | AL, CA, FL, VA |
Product
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
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.
Identifiers
| code_info | Lot Numbers: 39098746, 39655101, 39985370, 40067795 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0345-2016%22
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