Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000,…
Medical device recall Z-0814-2025. 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
- 1573 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 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992
1573 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574; REF 1107-9604-000, GTIN 00840682112925; REF 1107-9610-000, GTIN 00840682112864; REF 1107-9612-000, GTIN 00840682113236;…
Every code shown here, 1,995 characters
REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574; REF 1107-9604-000, GTIN 00840682112925; REF 1107-9610-000, GTIN 00840682112864; REF 1107-9612-000, GTIN 00840682113236; REF 1107-9616-000, GTIN 00840682113069; REF 1107-9617-000, GTIN 00840682112666; REF 2066835-001, GTIN 00840682112857; REF 2069767-001, GTIN 00840682112505; REF 2078800-001, GTIN 00840682112512; REF 2091008-001, GTIN 00840682112437; REF 2091009-001, GTIN 00840682112802; REF M1098876, GTIN 00840682112710; REF M1145610, GTIN 00840682112765; REF M1220023, GTIN 00840682112789; REF M1220854, GTIN 00840682112826; REF M1221495, GTIN 00840682115902; REF M1233992, GTIN 00840682112451; Serial Numbers: AESC31001 AESC31009 AESC32001 AESC32004 AESC32007 AESC29004 AESD02013 AESC11019 AESC11022 AESC13002 AESC13024 AESC24015 AESC25017 AESC28017 AESC22013 AESD15005 AESD15011 AESC13011 AESC23007 AESC25004 AESD31023 AESC13020 AESC16013 AESC17013 AESC20007 AESC22007 AESC22020 AESC23005 AESC23009 AESC23012 AESC29031 AESC11018 AESD15009 AESD15017 AESD16001 AESC50022 AESD08005 AESD10013 AESD10016 AESD11012 AESD11013 AESD12001 AESD12002 AESD12011 AESD20017 AESD22023 AESC30010 AESC42010 AESC42018 AESC43024 AESC43028 AESC44003 AESC44004 AESC44006 AESC44019 AESD31013 AESD31028 AESD01017 AESC46003 AESC47012 AESC48003 AESC48011 AESC11020 AESC23051 AESC13017 AESC30015 AESD15001 AESC24024 AESC10013 AESC21027 AESC45012 AESC48004 AESC50006 AESC50010 AESD07008 AESC30019 AESC32006 AESC43027 AESD13015 AESC45010 AESC43025 AESC50004 AESC50003 AESC50018 AESC50023 AESC50026 AESC51011 AESC50009 AESD07011 AESD08002 AESD08003 AESD08004 AESD08007 AESD08010 AESD08011 AESD08017 AESD09006 AESD11001 AESC29020 AESC24004 AESC29025 AESD31001 AESD31025 AESC44016 AESC11021 AESC03005 AESC08007 AESD12007 AESD12012 AESD12013 AESD12014 AESD14007 AESB49025 AESC13013 AESC21029 AESC21033 AESD15014 AESC21002 AESC32003 AESC45001 AESC45009 AESC45014 AESC49004 AESC09010 AESC10009 AESC11013…
FDA’s list runs to 16,464 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 16,464 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.