# FDA recall Z-0395-2018

> **Measurement Specialties Inc** · Class II · device recall initiated 2017-03-13.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0395-2018
- **Recalling firm:** Measurement Specialties Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-03-13
- **Report date:** 2018-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0395-2018

## Citation

> AI Analytics. FDA recall Z-0395-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0395-2018. Source: US FDA. Licensed CC0.

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