Medi-Therm Hyper/Hypothermia System, MTA7900
Medical device recall Z-2058-2017. Published in FDA’s Enforcement Report on May 17, 2017.
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 May 17, 2017. 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
- 119 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medi-Therm Hyper/Hypothermia System, MTA7900
119, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers MTA7900A01004 MTA7900A01021 MTA7900A01029 MTA7900A01036 MTA7900A01037 MTA7900A80003 MTA7900A80004 MTA7900A80011 MTA7900A80016 MTA7900A80026 MTA7900A80027 MTA7900A80029 MTA7900A80030 MTA7900A80034 MTA7900A80035 MTA7900A80045…
Every code shown here, 1,680 characters
Serial Numbers MTA7900A01004 MTA7900A01021 MTA7900A01029 MTA7900A01036 MTA7900A01037 MTA7900A80003 MTA7900A80004 MTA7900A80011 MTA7900A80016 MTA7900A80026 MTA7900A80027 MTA7900A80029 MTA7900A80030 MTA7900A80034 MTA7900A80035 MTA7900A80045 MTA7900A90006 MTA7900A90009 MTA7900A90023 MTA7900B90011 MTA7900B90019 MTA7900B90034 MTA7900B90036 MTA7900B90039 MTA7900C01016 MTA7900C01017 MTA7900D01015 MTA7900D01025 MTA7900D01029 MTA7900D80004 MTA7900D80018 MTA7900D80026 MTA7900D80030 MTA7900D80034 MTA7900D80035 MTA7900D80040 MTA7900E01018 MTA7900E01020 MTA7900E01023 MTA7900E01026 MTA7900E01028 MTA7900E01030 MTA7900E01034 MTA7900E01036 MTA7900E01041 MTA7900E80013 MTA7900E80047 MTA7900E80068 MTA7900E80077 MTA7900E90018 MTA7900E90028 MTA7900F01001 MTA7900F01007 MTA7900F01013 MTA7900F01015 MTA7900F01026 MTA7900F01035 MTA7900F01036 MTA7900F01038 MTA7900F01042 MTA7900F01049 MTA7900F01052 MTA7900F90019 MTA7900F90027 MTA7900F90030 MTA7900G01001 MTA7900G01002 MTA7900G01003 MTA7900G01006 MTA7900G01007 MTA7900G01008 MTA7900G01009 MTA7900G01012 MTA7900G01016 MTA7900G01017 MTA7900G01023 MTA7900G01025 MTA7900G90002 MTA7900G90003 MTA7900H80001 MTA7900H80004 MTA7900H80015 MTA7900H80030 MTA7900H90013 MTA7900I80003 MTA7900I80013 MTA7900I80035 MTA7900I90030 MTA7900J70001 MTA7900J70003 MTA7900J70006 MTA7900J70007 MTA7900J70008 MTA7900J70009 MTA7900J70010 MTA7900J70011 MTA7900J70013 MTA7900J70017 MTA7900J70018 MTA7900J70021 MTA7900J70030 MTA7900J70034 MTA7900J80044 MTA7900J80047 MTA7900J80049 MTA7900J80056 MTA7900J90030 MTA7900J90038 MTA7900K80009 MTA7900K90011 MTA7900K90012 MTA7900K90020 MTA7900K90028 MTA7900K90042 MTA7900K90062 MTA7900L70001 MTA7900L80006 MTA7900L80008 MTA7900L90013
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.
USA (nationwide) Distribution and Internationally to Colombia.
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 Mar 29, 2017.
- FDA classified it on May 10, 2017.
- FDA’s Enforcement Report published it on May 17, 2017.
- FDA terminated it on Sep 18, 2017.
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.”
- 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.