RecallRadar

FDA Device recall Z-0818-2025

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

On 2025-01-15 the FDA classified a Class II recall of Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV 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

AgencyFDA Device
Recall numberZ-0818-2025
ClassificationClass II
Statusongoing
Initiated2024-11-18
Published2025-01-15
Last updated2026-09-13 11:57 UTC
CompanyGe Medical Systems
DistributionUS

Product

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

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
GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 S…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 SQ

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-0818-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.