Stryker Medi-Therm Hyper/Hypothermia System Recalled for Water Reheating Issue
Stryker is recalling 119 Medi-Therm Hyper/Hypothermia Systems because the water may reheat too quickly under specific operating conditions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that could cause harm (overheating) without reported injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 119 units of the Medi-Therm Hyper/Hypothermia System, model MTA7900. The recall was initiated because the water in the system 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.
The affected units were distributed nationwide in the United States and internationally to Colombia. The recall covers specific serial numbers listed in the agency's official documentation.
Consumers and healthcare facilities should stop using the affected units and contact Stryker for instructions on how to proceed with the recall.
The recalled product
- Product
- Medi-Therm Hyper/Hypothermia System, MTA7900
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Hazard
- Affected units
- 119
Distribution
Distributed nationwide across the United States.
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