The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying…
Medical device recall Z-0933-2014. Published in FDA’s Enforcement Report on Feb 12, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 12, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1002 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature display while the unit is in Auto mode. While in Auto mode, only the patient temperature is displayed along with the set point. The water display will be blank during Auto mode. If the user wants to see the water temperature displayed and switches out of Auto mode to Manual mode, then back to
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device’s control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.
1002 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020…
Every code shown here, 1,998 characters
Domestic Serial Numbers MTA7900C01023 MTA7900E01043 MTA7900F01021 MTA7900F90020 MTA7900G90007 MTA7900B90022 MTA7900B90023 MTA7900D80022 MTA7900B01006 MTA7900B01009 MTA7900B01012 MTA7900H90007 MTA7900H90008 MTA7900A01019 MTA7900A01020 MTA7900A01024 MTA7900D01028 MTA7900F01002 MTA7900H80009 MTA7900H80021 MTA7900G90016 MTA7900H90006 MTA7900K90056 MTA7900K90061 MTA7900K90063 MTA7900L90003 MTA7900L90006 MTA7900L90020 MTA7900H80057 MTA7900E01016 MTA7900I90006 MTA7900I90038 MTA7900B90020 MTA7900E80014 MTA7900E80020 MTA7900E80027 MTA7900I90023 MTA7900I90027 MTA7900E90031 MTA7900I90031 MTA7900I90041 MTA7900H90004 MTA7900B80004 MTA7900A80028 MTA7900E80054 MTA7900E01042 MTA7900D80001 MTA7900C01012 MTA7900J90018 MTA7900A01028 MTA7900E80046 MTA7900J70023 MTA7900J70024 MTA7900J70025 MTA7900J70026 MTA7900J70027 MTA7900J70031 MTA7900J70032 MTA7900E80011 MTA7900E80035 MTA7900H80014 MTA7900H80018 MTA7900H80019 MTA7900A90017 MTA7900K80010 MTA7900K80011 MTA7900K80012 MTA7900K80013 MTA7900L80001 MTA7900L80004 MTA7900L80013 MTA7900E80059 MTA7900A01014 MTA7900H90019 MTA7900H90020 MTA7900H90021 MTA7900H90022 MTA7900H90023 MTA7900D80055 MTA7900J90035 MTA7900J70028 MTA7900H80023 MTA7900A80032 MTA7900J70029 MTA7900I80029 MTA7900C80001 MTA7900C80002 MTA7900C80003 MTA7900J90027 MTA7900D80006 MTA7900E80029 MTA7900E80040 MTA7900E80065 MTA7900D01022 MTA7900E01022 MTA7900B01036 MTA7900F01010 MTA7900D90030 MTA7900K90003 MTA7900C01009 MTA7900C01025 MTA7900J60008 MTA7900A01032 MTA7900K90004 MTA7900E01029 MTA7900E90017 MTA7900J70022 MTA7900K90019 MTA7900B01040 MTA7900B01043 MTA7900B01024 MTA7900A90001 MTA7900A90005 MTA7900A90008 MTA7900E80022 MTA7900G80009 MTA7900G80011 MTA7900H80002 MTA7900H80003 MTA7900H80006 MTA7900H80007 MTA7900H80008 MTA7900H80010 MTA7900H80011 MTA7900H80012 MTA7900H80013 MTA7900L70008 MTA7900L70009 MTA7900G60063 MTA7900K40071 MTA7900B01019 MTA7900F01014 MTA7900C90010 MTA7900J80039 MTA7900K90053 MTA7900K90054 MTA7900A90012 MTA7900A90016 MTA7900A90020 MTA7900J90036 MTA7900K80005…
FDA’s list runs to 13,688 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
nationwide and worldwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 27, 2013.
- FDA classified it on Feb 5, 2014.
- FDA’s Enforcement Report published it on Feb 12, 2014.
- FDA terminated it on Nov 4, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Medical Division of Stryker Corporation, of Portage, MI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,688 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.