Data Foundry

Medical device recalls 2025

Tec 6 Plus Anesthesia Vaporizer — Class II medical device recall Z-0814-2025

Ongoing recall by GE Medical Systems, LLC, reported 2025-01-15, distributed nationwide. Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic age

Recall numberZ-0814-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmGE Medical Systems, LLC, Waukesha, WI, United States
Recall initiated2024-11-18
Classified2025-01-07
Reported by FDA2025-01-15
DistributedNationwide (US)
Quantity1,573 units
UPC / GTIN / UDI-DI00840682112437, 00840682112451, 00840682112505, 00840682112512, 00840682112574, 00840682112659, 00840682112666, 00840682112710, 00840682112765, 00840682112789, 00840682112802, 00840682112826, 00840682112857, 00840682112864, 00840682112925, 00840682113069, 00840682113236, 00840682115902
Serial numbersAESB07001, AESB10007, AESB10008, AESB11014, AESB23021, AESB24010, AESB33008, AESB33013, AESB33026, AESB37011, AESB40007, AESB40017, AESB40023, AESB49025, AESC02001, AESC03005, AESC04023, AESC05025, AESC06026, AESC06034, AESC08003, AESC08006, AESC08007, AESC08022, AESC09010 and 475 more
Model numbers1107-9601-000, 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, M1233992

Product

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

Reason for recall

Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0814-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.