Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Medical device recall Z-0816-2025. 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
- 928 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 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
928 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00840682124720; Serial Numbers: SQBC04329 SQBD02691 SQBD02759 SQBD03566 SQBD03635 SQBD03805 SQBD04084 SQBD04327 SQBD04374 SQBD04623 SQBD00017 SQBD00156 SQBD00219 SQBD00327 SQBD00356 SQBD00357 SQBD00366 SQBD01512 SQBD01626 SQBD01733…
Every code shown here, 1,998 characters
GTIN: 00840682124720; Serial Numbers: SQBC04329 SQBD02691 SQBD02759 SQBD03566 SQBD03635 SQBD03805 SQBD04084 SQBD04327 SQBD04374 SQBD04623 SQBD00017 SQBD00156 SQBD00219 SQBD00327 SQBD00356 SQBD00357 SQBD00366 SQBD01512 SQBD01626 SQBD01733 SQBC02274 SQBC02744 SQBC02888 SQBC02893 SQBC02904 SQBC02961 SQBC02965 SQBC02968 SQBC02963 SQBC02964 SQBC00922 SQBC03323 SQBC03324 SQBC03329 SQBD02266 SQBD02395 SQBD02631 SQBD02768 SQBD03913 SQBD03925 SQBD01924 SQBD01927 SQBD01931 SQBD00407 SQBD00408 SQBD00417 SQBD00430 SQBC03018 SQBC03827 SQBD00077 SQBC05092 SQBC05653 SQBC00596 SQBC02583 SQBC02603 SQBC02605 SQBC02632 SQBC02633 SQBC04136 SQBC04180 SQBC04970 SQBC04984 SQBC04987 SQBC04994 SQBC05000 SQBC05002 SQBC05007 SQBC05009 SQBC05010 SQBC05011 SQBC05014 SQBC05023 SQBC05026 SQBC05028 SQBC01689 SQBC02597 SQBD00002 SQBD00082 SQBD00019 SQBD00010 SQBD00027 SQBC03600 SQBC03948 SQBC04612 SQBC05584 SQBC04999 SQBC05104 SQBC05251 SQBC05106 SQBC05176 SQBC05204 SQBC05303 SQBD00003 SQBC05315 SQBD00012 SQBD00071 SQBD00073 SQBD00079 SQBD00083 SQBD00096 SQBD00103 SQBD00106 SQBC05785 SQBC05806 SQBD00013 SQBC05645 SQBD00011 SQBC05690 SQBC05650 SQBC05752 SQBC05027 SQBC05030 SQBC02600 SQBC04950 SQBC04986 SQBC05025 SQBC05649 SQBC05756 SQBD00074 SQBD00075 SQBD00085 SQBD00088 SQBD00097 SQBC04884 SQBC04891 SQBC04911 SQBC04912 SQBC04915 SQBD00018 SQBC05280 SQBC04610 SQBC03586 SQBC03793 SQBC04164 SQBC04886 SQBC04908 SQBC04909 SQBC04910 SQBC04913 SQBC05032 SQBC00553 SQBC01661 SQBC01671 SQBC01672 SQBC01673 SQBC01681 SQBC01690 SQBC01698 SQBC01712 SQBC01716 SQBC01724 SQBC01742 SQBC01758 SQBC02626 SQBC02661 SQBC04044 SQBC04054 SQBC04085 SQBC04086 SQBC04157 SQBC04863 SQBC01377 SQBC01718 SQBC02092 SQBC02370 SQBC02619 SQBC02624 SQBC02645 SQBC02651 SQBC02657 SQBC02659 SQBC02662 SQBC04527 SQBC04614 SQBC02587 SQBC03672 SQBC03753 SQBC03830 SQBC03850 SQBC04046 SQBC04049 SQBC04052 SQBC04090 SQBC04592 SQBC04599 SQBC04601 SQBC04604 SQBC04606 SQBC04611 SQBC04615 SQBC04620 SQBC04642 SQBC01160 SQBC01163 SQBC01167 SQBC01209…
FDA’s list runs to 9,317 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 9,317 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.