FDA Device recall Z-0816-2025
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0816-2025 |
| 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 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-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: 00840682124720; Serial Numbers: SQBC04329 SQBD02691 SQBD02759 SQBD03566 SQBD03635 SQBD03805 SQBD04084 SQBD04327 S…GTIN: 00840682124720; Serial Numbers: SQBC04329 SQBD02691 SQBD02759 SQBD03566 SQBD03635 SQBD03805 SQBD04084 SQBD04327 SQBD04374 SQBD04623 SQBD00017 SQBD00156 SQBD00219 SQBD00327 SQBD00356 SQBD00357 SQBD00366 SQBD01512 SQBD01626 SQBD01733 SQBC02274 SQBC02744 SQBC02888 SQBC02893 SQBC02904 SQBC02961 SQBC02965 SQBC02968 SQBC02963 SQBC02964 SQBC00922 SQBC03323 SQBC03324 SQBC03329 SQBD02266 SQBD02395 SQBD02631 SQBD02768 SQBD03913 SQBD03925 SQBD01924 SQBD01927 SQBD01931 SQBD00407 SQBD00408 SQBD00417 SQBD00430 SQBC03018 SQBC03827 SQBD00077 SQBC05092 SQBC05653 SQBC00596 SQBC02583 SQBC02603 SQBC02605 SQBC02632 SQBC02633 SQBC04136 SQBC04180 SQBC04970 SQBC04984 SQBC04987 SQBC04994 SQBC05000 SQBC05002 SQBC05007 SQBC05009 SQBC05010 SQBC05011 SQBC05014 SQBC05023 SQBC05026 SQBC05028 SQBC01689 SQBC02597 SQBD00002 SQBD00082 SQBD00019 SQBD00010 SQBD00027 SQBC03600 SQBC03948 SQBC04612 SQBC05584 SQBC04999 SQBC05104 SQBC05251 SQBC05106 SQBC05176 SQBC05204 SQBC05303 SQBD00003 SQBC05315 SQBD00012 SQBD00071 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-0816-2025%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.