Altrix¿ Precision Temperature Management System
Medical device recall Z-0235-2019. Published in FDA’s Enforcement Report on Oct 31, 2018.
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 Oct 31, 2018. 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
- 389 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?
Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond 0.5¿C while in Automatic mode. 2. Users may experience a Remove from Use code 9 (RFU 9) fault condition relating to inadvertent flow alarms.3. Users may experience code RFU 27 fault condition relating to mechanical interference between the device fan and filter
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with prescription privileges determines that temperature therapy is necessary or desirable.
389 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model numbers/ UDI: 8001000001 07613327277555; 8001000003 07613327277562; 8001000008 07613327277630; 8001000015 07613327277722; 8001000016 07613327277586; 8001000017 07613327277609; 8001000018 07613327277678; 8001000019 07613327277623;…
Every code shown here, 1,998 characters
Model numbers/ UDI: 8001000001 07613327277555; 8001000003 07613327277562; 8001000008 07613327277630; 8001000015 07613327277722; 8001000016 07613327277586; 8001000017 07613327277609; 8001000018 07613327277678; 8001000019 07613327277623; 8001000023 07613327277777 Altrix model 8001 units manufactured between October 4, 2016 and June 30, 2017: Serial Numbers: US: 201612000100044 201612000100034 201612000100126 201612000100127 201612000100129 201612000100134 201612000100136 201612000100003 201612000100004 201612000100005 201612000100007 201612000100009 201612000100111 201612000100112 201702000100045 201702000100101 201702000100102 201702000100103 201702000100104 201702000100108 201702000100110 201703000100074 201702000100116 201701000100142 201702000100051 201702000100105 201612000100106 Serial Numbers: OUS 201609000500040 201609000500041 201609000500042 201609000500043 201701000500049 201701000500050 201611000100095 201611000100094 201611000100096 201611000100097 201611000100126 201611000100098 201611000100118 201611000100119 201611000100120 201611000100121 201611000100122 201611000100123 201611000100124 201611000100125 201611000100127 201611000100137 201611000100138 201611000100139 201611000100140 201611000100141 201609000500005 201609000500001 201609000500002 201609000500003 201609000500004 201609000500006 201609000500007 201609000500008 201609000500009 201609000500010 201609000500011 201609000500012 201609000500013 201609000500039 201609000500050 201610000500062 201610000500066 201610000500067 201610000500075 201609000500014 201611000500053 201611000500091 201611000500097 201611000500098 201611000500099 201611000500100 201611000500062 201611000500055 201611000500056 201611000500057 201611000500060 201611000500061 201611000500093 201611000500063 201611000500096 201610000500072 201610000500063 201610000500073 201610000500074 201703000500001 201703000500003 201703000500004 201703000500021 201703000500025 201703000500027 201610000500069 201610000500070 201610000500076…
FDA’s list runs to 3,387 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.
Worldwide - US Nationwide Distribution and the countries of Foreign: Australia, Canada, Netherlands, Switzerland and United Kingdom
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 Sep 6, 2018.
- FDA classified it on Oct 23, 2018.
- FDA’s Enforcement Report published it on Oct 31, 2018.
- FDA terminated it on Apr 13, 2020.
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 3,387 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.