Measurement Specialties Reusable Temperature Probe Autoclavable — Class II medical device recall Z-0395-2018
Ongoing recall by Measurement Specialties Inc, reported 2018-01-31, distributed nationwide. The reusable temperature probes are provided with instructions for sterilization that have not been proven thr
| Recall number | Z-0395-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Measurement Specialties Inc, Andover, MN, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, GB, IE, IL, IN, IT, JP, KR, MY, NL, SG, TW, VN, ZA |
| Quantity | 6,076 devices |
| Lot numbers | 11M57610, 12A50150, 12A54328, 12B55182, 12B56215, 12B59416, 12B59529, 12B59570, 12B60056, 12C56215, 12C57285, 12C60069, 12D59168, 12D61023, 12D61386, 12D61829, 12E57286, 12F55548, 12F59571, 12F60692, 12F62179, 12H65752, 12H65787, 12H65961, 12J65322, 12J66632, 12J66809, 12K63370, 12K66633, 12K67454, 12K67533, 12L54648, 12L68344, 12L68584, 12M63372, 12M64134, 12M68130, 12M69229, 13A69334, 13A69520 and 90 more |
| Model numbers | 401AC, 402AC, 409AC |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0395-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.