Stryker Recalls Gaymar Medi-Therm Devices Due to Missing Water Temperature Display
Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect involves a missing display rather than a direct mechanical failure causing injury, fitting the Moderate category for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 1,002 units of the Gaymar Medi-Therm device. The recall is due to a defect where the water temperature display is blank while the unit is operating in Auto mode. In this mode, only the patient temperature and set point are displayed, leaving the water temperature field empty.
The Gaymar Medi-Therm device is used to regulate patient temperature by supplying temperature-controlled water to accessory blankets or body wraps. The device controls output water temperature by mixing hot and cold water using solenoid valves under microprocessor control. The affected units were distributed nationwide and worldwide.
Users who switch from Auto mode to Manual mode and back to Auto mode may observe the water temperature display. However, the source text does not specify if this workaround is recommended or if the display functions correctly in Manual mode. Consumers and healthcare facilities should check their device serial numbers against the list provided by the FDA and contact Stryker for instructions on repair or replacement.
The recalled product
- Product
- The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling…
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 1,002
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Medical Division of Stryker Corporation
See all →- ModerateStryker Cub pediatric cribs sold in USA missing two warning labels
FDA (Devices) · 2026-03-25
- ModerateBariatric hospital beds recalled because they are not tested with certain mattresses
FDA (Devices) · 2025-12-17
- ModerateHospital mattresses recalled because they are not tested with certain beds
FDA (Devices) · 2025-12-17
- HighProCurity patient beds recalled for electrical safety testing defects
FDA (Devices) · 2023-12-13
- HighProCuity Hospital Patient Beds Recalled for Missing Electrical Safety Testing
FDA (Devices) · 2023-12-13
Same hazard · display defect
See all →- HighBlood glucose meters recalled over display segments that can misread values
FDA (Devices) · 2025-11-05
- HighDiagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export
FDA (Devices) · 2024-05-01
- HighTactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System
FDA (Devices) · 2024-01-31
- HighPhilips Incisive CT Scanner Software Issues May Cause Misdiagnosis
FDA (Devices) · 2024-01-17
- ModerateWelch Allyn Connex Spot Monitor Recalled for Improper Copper Tape Placement
FDA (Devices) · 2023-09-20
Similar recalls
- HighStryker Medi-Therm Hyper/Hypothermia System Recalled for Water Reheating Issue
FDA (Devices) · 2017-05-17
- ModerateStryker Altrix Temperature Management System Recalled for Alarm Faults
FDA (Devices) · 2018-10-31
- High3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk
FDA (Devices) · 2018-02-21
- High3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk
FDA (Devices) · 2018-02-21
- HighGentherm Medical Recalls Blanketrol III Thermal Regulating Systems
FDA (Devices) · 2026-08-26
- ModerateMedical cooler-heater device recalled for inadequate maintenance and inspection guidance
FDA (Devices) · 2021-10-13