FDA Device recall Z-0817-2025
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO 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-0817-2025 |
| 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 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
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: 00840682124751; Serial Numbers: SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 S…GTIN: 00840682124751; Serial Numbers: SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135 SQAD00148 SQAD01165 SQAC01012 SQAC01014 SQAD00107 SQAD00758 SQAD00767 SQAD00790 SQAC01172 SQAC00827 SQAC00835 SQAD00497 SQAC01111 SQAC01160 SQAC01180 SQAC01182 SQAC01183 SQAC00902 SQAC00904 SQAD00674 SQAD00677 SQAC00976 SQAD01129 SQAD01143 SQAD00045 SQAD00047 SQAD00181 SQAD00187 SQAC01376 SQAC01379 SQAC00666 SQAC00668 SQAC01019 SQAD00161 SQAD00168 SQAD00169 SQAD00178 SQAD00179 SQAC00908 SQAC00584 SQAC00876 SQAC00841 SQAD01178 SQAC00789 SQAD00120 SQAD00141 SQAD00482 SQAD00517 SQAD00519 SQAD00520 SQAD00521 SQAD00522 SQAD00530 SQAD00864 SQAD00866 SQAD00868 SQAD00869 SQAD00872 SQAD00874 SQAD00877 SQAD00878 SQAD00890 SQAD00891 SQAD00892 SQAD00895 SQAD00896 SQAD00897 SQAD00899 SQAD00905 SQAC01007 SQAD00787 SQAD00793 SQAD00810 SQAD00814 SQAC00967 SQAC00968 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-0817-2025%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.