FDA Device recall Z-0814-2025

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…

FDA Device
Class II
ongoing
Published 2025-01-15

On 2025-01-15 the FDA classified a Class II recall of 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… by Ge Medical Systems, citing due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0814-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-18
Published	2025-01-15
Last updated	2026-09-13 11:57 UTC
Company	Ge Medical Systems
Distribution	US

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

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

Identifiers

code_info	REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574… 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 AESC20

code_info

REF 1107-9601-000, GTIN 0084068211253; REF 1107-9602-000, GTIN 00840682112659; REF 1107-9603-000, GTIN 00840682112574…

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 AESC20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0814-2025%22

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