DeRoyal Industries Inc: Medical Device Recall in 2015 - (Recall #: Z-0345-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.

Product Classification:

Class II

Date Initiated: October 14, 2015

Date Posted: December 9, 2015

Recall Number: Z-0345-2016

Event ID: 72454

Reason for Recall:

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.

Status: Terminated

Product Quantity: 16 cases of 50 units (800 eaches)

Code Information:

Lot Numbers: 39098746, 39655101, 39985370, 40067795

Distribution Pattern:

Distributed in the states of VA, AL, FL, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated