Measurement Specialties Inc: Medical Device Recall in 2018 - (Recall #: Z-0395-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designed to be used with any patient monitoring system designed to accept 400 Series temperature probes.

Product Classification:

Class II

Date Initiated: March 13, 2017

Date Posted: January 31, 2018

Recall Number: Z-0395-2018

Event ID: 78036

Reason for Recall:

The reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study.

Status: Ongoing

Product Quantity: 6,076 devices total

Code Information:

Part No. 401AC (Lot No. 14K87246, 15M96863, 13E72645, 12D61386, 13D72302, 16B97593, 15C91286, 13B64377, 14J86547, 12B59416, 13A69334, 15K95972, 15A97196, 15E92377, 15F92378, 13L77336, 12D61023, 14G84704, 14K87499, 14F84193, 13L77335, 16B97594, 15C91419, 13B70167, 15C91448, 15E92375, 15K96046, 16A97197, 12B59529, 16B97798, 15K96125, 16B97595, 15L96777, 12D61829, 13D72644, 15A89998, 13F73449, 12M64134, 15L96745, 15D90215, 15H95035, 13F74403, 13L78489, 13L77336, 12H65961, 14G84878, 12F62179, 14J87014, 12B55182, 14F84444, 14J87081, 13L77336, 13L78489, 14F84400, 12J66632, 16A97380, 12M68130, 15E92376, 14L88737, 14L87904, 12K66633, 13H74994, 13H74995, 12B60056, 12C57285, 14H86266, 16A97592, 14J87164, 12D59168, 14M89765, 12A54328, 15A89854, 14F84634, 14G84624, 15M96829, 15K95896); Part No. 402AC (Lot No. 13E73262, 15E92379, 12E57286, 12L68344, 15E93385, 12H65752, 12H65787, 15F92380, 12J65322, 15F92381, 12K67454, 15A89941, 15A89282, 13H75930, 12F55548, 12K67533, 13H75930, 12J66809, 12B59570, 15E92010, 12A50150, 14E83393); Part No. 409AC (Lot No. 12C56215, 12B56215, 15C90920, 15K28358, 12C60069, 13B70035, 16B97312, 13A69520, 14E83602, 13E73264, 12L68584, 11M57610, 12F59571, 15B90832, 15E92560, 12K63370, 16B97614, 12L54648, 15D92011, 12M63372, 14H85773, 16B97615, 15M97109, 16B97805, 12M69229, 15A89939, 15A90196, 12F60692, 14L88520, 14L88519, 13A70145, 15E92382, 15A90466, 13E73450, 15F92383, 13D72925)

Distribution Pattern:

USA (nationwide) distribution to the states of : AL, CA, KY, IL, KS, MN, NY, OH, TX, VA and WI. Distributed internationally to: Australia, Canada, China, England, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Singapore, South Africa, South Korea, Taiwan, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated