Data Foundry

Medical device recalls 2017

Medi-Therm Hyper/Hypothermia System — Class II medical device recall Z-2058-2017

Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2017-05-17, distributed nationwide. The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water t

Recall numberZ-2058-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Medical Division of Stryker Corporation, Portage, MI, United States
Recall initiated2017-03-29
Classified2017-05-10
Reported by FDA2017-05-17
Terminated2017-09-18
DistributedNationwide (US)
Countries outside the USCO
Quantity119
Serial numbersMTA7900A01004, MTA7900A01021, MTA7900A01029, MTA7900A01036, MTA7900A01037, MTA7900A80003, MTA7900A80004, MTA7900A80011, MTA7900A80016, MTA7900A80026, MTA7900A80027, MTA7900A80029, MTA7900A80030, MTA7900A80034, MTA7900A80035, MTA7900A80045, MTA7900A90006, MTA7900A90009, MTA7900A90023, MTA7900B90011, MTA7900B90019, MTA7900B90034, MTA7900B90036, MTA7900B90039, MTA7900C01016 and 94 more

Product

Medi-Therm Hyper/Hypothermia System, MTA7900

Reason for recall

The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.

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-2058-2017. 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.