Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Medical device recall Z-0818-2025. 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
- 8319 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 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
8319 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 SQBC05635 SQBC05637 SQBC05641 SQBC05642 SQBC03558 SQBD03089 SQBD04439 SQBD04457 SQBD04459 SQBD04468 SQBD04702 SQBC04948…
Every code shown here, 1,998 characters
GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 SQBC05635 SQBC05637 SQBC05641 SQBC05642 SQBC03558 SQBD03089 SQBD04439 SQBD04457 SQBD04459 SQBD04468 SQBD04702 SQBC04948 SQBC05702 SQBD02556 SQBC03896 SQBC04666 SQBC03225 SQBD02978 SQBD01384 SQBC02115 SQBC02023 SQBD04606 SQBD01484 SQBD04811 SQBC03549 SQBC03554 SQBC03559 SQBC03888 SQBC03970 SQBC04507 SQBD00211 SQBC02666 SQBC02959 SQBD00220 SQBD00402 SQBC01921 SQBC02087 SQBC02330 SQBC03003 SQBC01843 SQBC01855 SQBC04513 SQBD00326 SQBC05544 SQBC01450 SQBC02011 SQBC04529 SQBD01491 SQBD04711 SQBC01581 SQBC01747 SQBC02108 SQBC02162 SQBC02165 SQBC02183 SQBC02595 SQBC03023 SQBC05440 SQBD00444 SQBD00581 SQBC02204 SQBC02837 SQBD02999 SQBC01275 SQBC01279 SQBC01280 SQBC01283 SQBC01286 SQBC03723 SQBC02951 SQBD03058 SQBC03476 SQBD01380 SQBC03932 SQBC03969 SQBD04515 SQBD01481 SQBD01489 SQBD01315 SQBC01923 SQBD04013 SQBD04032 SQBD04034 SQBD04292 SQBD04307 SQBC02190 SQBC01912 SQBC05459 SQBD02862 SQBD02869 SQBD02886 SQBC02729 SQBC02747 SQBC01321 SQBC01322 SQBC01333 SQBD00159 SQBD02160 SQBC04115 SQBD02228 SQBD02276 SQBC02688 SQBC02753 SQBC02902 SQBD04016 SQBC01702 SQBC01811 SQBC01857 SQBC01864 SQBC01867 SQBC01869 SQBC01871 SQBC01872 SQBC01873 SQBC03257 SQBD04646 SQBD04058 SQBD04065 SQBC02014 SQBC02020 SQBD00130 SQBD04615 SQBC05293 SQBD00470 SQBD00474 SQBD00522 SQBC05037 SQBC02025 SQBD02635 SQBD02736 SQBD02738 SQBD02751 SQBD02754 SQBC04123 SQBD01505 SQBD01510 SQBD04630 SQBC05782 SQBC02814 SQBD00160 SQBD00161 SQBD00172 SQBC03066 SQBD04342 SQBD04052 SQBD04123 SQBD04242 SQBD04250 SQBD04287 SQBD04304 SQBD04325 SQBD04344 SQBD04346 SQBD04271 SQBD03156 SQBD02176 SQBC05369 SQBD03652 SQBD01267 SQBC04784 SQBC05013 SQBC05427 SQBC03055 SQBC03059 SQBC03090 SQBC03117 SQBC03119 SQBC03124 SQBC03127 SQBC03128 SQBC03129 SQBC03424 SQBC03515 SQBC03555 SQBC03560 SQBC03567 SQBC03576 SQBC05768 SQBC05773 SQBC05775 SQBC05776 SQBC05777 SQBD00239 SQBD04355 SQBD05023 SQBD04317 SQBD02837 SQBD02838…
FDA’s list runs to 83,239 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 83,239 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.