Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Medical device recall Z-0815-2025. 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
- 644 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 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
644 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 00840682124744; Serial Numbers: SQAD01037 SQAD01038 SQAD01041 SQAC01464 SQAC01467 SQAC00988 SQAC00987 SQAD01184 SQAD01219 SQAD01221 SQAD01222 SQAC01106 SQAD00048 SQAD00057 SQAD00059 SQAD00116 SQAD00124 SQAD00127 SQAD00129 SQAD00134…
Every code shown here, 1,998 characters
GTIN: 00840682124744; Serial Numbers: SQAD01037 SQAD01038 SQAD01041 SQAC01464 SQAC01467 SQAC00988 SQAC00987 SQAD01184 SQAD01219 SQAD01221 SQAD01222 SQAC01106 SQAD00048 SQAD00057 SQAD00059 SQAD00116 SQAD00124 SQAD00127 SQAD00129 SQAD00134 SQAD00136 SQAD00137 SQAD00139 SQAD00144 SQAD00576 SQAD00577 SQAD00581 SQAC00844 SQAC00851 SQAC00852 SQAC00854 SQAC00855 SQAC00856 SQAC00857 SQAC00858 SQAC00930 SQAC00842 SQAC00895 SQAC00517 SQAC01192 SQAD00860 SQAC01203 SQAC00989 SQAC00990 SQAC01186 SQAD00142 SQAD00486 SQAD00498 SQAD00831 SQAD00853 SQAD00855 SQAD00856 SQAD00857 SQAD00862 SQAD00863 SQAD00871 SQAD00873 SQAD00881 SQAD00883 SQAD00887 SQAD01109 SQAD01117 SQAD01168 SQAD00704 SQAD00736 SQAD00720 SQAD00747 SQAD00754 SQAD00761 SQAD00784 SQAD01031 SQAD01033 SQAD00523 SQAD00527 SQAD00583 SQAC01468 SQAD00140 SQAD00143 SQAD00808 SQAC01367 SQAC01389 SQAC01397 SQAC01190 SQAD00870 SQAD00859 SQAC01424 SQAC00881 SQAC01457 SQAC01476 SQAC01494 SQAC01445 SQAC01373 SQAC01435 SQAC01447 SQAC01361 SQAD00202 SQAC00941 SQAD00438 SQAD00439 SQAD00441 SQAC00811 SQAC01451 SQAD00024 SQAC00953 SQAD00200 SQAD00201 SQAD00199 SQAD00412 SQAD00413 SQAD00414 SQAD00416 SQAD00417 SQAD00419 SQAD00420 SQAD00421 SQAD00422 SQAD00423 SQAD00424 SQAD00425 SQAD00427 SQAD00428 SQAD00429 SQAD00430 SQAD00431 SQAD00433 SQAD00434 SQAD00435 SQAD00198 SQAC01507 SQAD00017 SQAD00031 SQAD00189 SQAD00220 SQAC01503 SQAC01508 SQAC01453 SQAC01461 SQAD00203 SQAC01220 SQAC01224 SQAC01215 SQAC01232 SQAC01233 SQAC01237 SQAC01458 SQAC01281 SQAC00814 SQAD00844 SQAC01056 SQAC00938 SQAD00008 SQAD00016 SQAD00437 SQAD00832 SQAC01217 SQAC01223 SQAC01228 SQAC00927 SQAC01142 SQAC01143 SQAC01239 SQAC01462 SQAC00875 SQAC01032 SQAC01033 SQAC01046 SQAC01050 SQAC01052 SQAC01054 SQAC01055 SQAC01058 SQAC01060 SQAC01061 SQAC01063 SQAC01064 SQAC01066 SQAC01070 SQAC01071 SQAC01072 SQAC01214 SQAC01226 SQAC01227 SQAC01229 SQAC01238 SQAC01245 SQAC01248 SQAC01249 SQAC01259 SQAC01276 SQAC01277 SQAC01279 SQAC01282 SQAC01285 SQAC01466 SQAC01500 SQAD00375…
FDA’s list runs to 6,477 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 6,477 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.