Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Medical device recall Z-0817-2025. Published in FDA’s Enforcement Report on Jan 15, 2025.
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 Jan 15, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1594 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?
Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
1594 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00840682124751; Serial Numbers: SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135…
Every code shown here, 1,998 characters
GTIN: 00840682124751; Serial Numbers: SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135 SQAD00148 SQAD01165 SQAC01012 SQAC01014 SQAD00107 SQAD00758 SQAD00767 SQAD00790 SQAC01172 SQAC00827 SQAC00835 SQAD00497 SQAC01111 SQAC01160 SQAC01180 SQAC01182 SQAC01183 SQAC00902 SQAC00904 SQAD00674 SQAD00677 SQAC00976 SQAD01129 SQAD01143 SQAD00045 SQAD00047 SQAD00181 SQAD00187 SQAC01376 SQAC01379 SQAC00666 SQAC00668 SQAC01019 SQAD00161 SQAD00168 SQAD00169 SQAD00178 SQAD00179 SQAC00908 SQAC00584 SQAC00876 SQAC00841 SQAD01178 SQAC00789 SQAD00120 SQAD00141 SQAD00482 SQAD00517 SQAD00519 SQAD00520 SQAD00521 SQAD00522 SQAD00530 SQAD00864 SQAD00866 SQAD00868 SQAD00869 SQAD00872 SQAD00874 SQAD00877 SQAD00878 SQAD00890 SQAD00891 SQAD00892 SQAD00895 SQAD00896 SQAD00897 SQAD00899 SQAD00905 SQAC01007 SQAD00787 SQAD00793 SQAD00810 SQAD00814 SQAC00967 SQAC00968 SQAC00971 SQAC00972 SQAC00662 SQAC00763 SQAC00688 SQAC00665 SQAC00759 SQAC01008 SQAC01371 SQAC01402 SQAD01171 SQAD01172 SQAD01179 SQAD01150 SQAD01158 SQAD01163 SQAC00973 SQAC00978 SQAD01067 SQAC01001 SQAD00722 SQAD00723 SQAD00725 SQAD00726 SQAD00727 SQAD00728 SQAD00729 SQAD00731 SQAD00733 SQAD00739 SQAC01363 SQAC01370 SQAC00708 SQAC01372 SQAD00902 SQAC00899 SQAC00905 SQAD00765 SQAD00766 SQAD00769 SQAD00771 SQAD00772 SQAD00773 SQAD00774 SQAD00776 SQAD00782 SQAC00999 SQAC01000 SQAC01003 SQAC01004 SQAC01017 SQAD00356 SQAC01383 SQAC00524 SQAC00986 SQAC01463 SQAC00698 SQAC01410 SQAD00249 SQAD00385 SQAC00639 SQAD00745 SQAD00954 SQAC00777 SQAD00732 SQAD00804 SQAD00806 SQAD00807 SQAD00809 SQAC01251 SQAC01322 SQAD00248 SQAD00250 SQAD00252 SQAD00254 SQAD00257 SQAD00312 SQAD00313 SQAD00315 SQAD00054 SQAD00055 SQAD00183 SQAD00185 SQAD00239 SQAD00241 SQAD00688 SQAD00186 SQAD00194 SQAC01236 SQAC00657 SQAC00781 SQAC00782 SQAC00783 SQAC00784 SQAC00788 SQAC00792 SQAD00652 SQAD00130 SQAC01431 SQAD01229…
FDA’s list runs to 15,977 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.
US Nationwide. Global Distribution.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Nov 18, 2024.
- FDA classified it on Jan 7, 2025.
- FDA’s Enforcement Report published it on Jan 15, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, LLC, of Waukesha, WI.
- 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 15,977 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
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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.