Tec 820 ISO Anesthesia Vaporizer — Class II medical device recall Z-0815-2025
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 number | Z-0815-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2024-11-18 |
| Classified | 2025-01-07 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 644 units |
| UPC / GTIN / UDI-DI | 00840682124744 |
| Serial numbers | SQAC00509, SQAC00511, SQAC00513, SQAC00517, SQAC00529, SQAC00530, SQAC00603, SQAC00633, SQAC00641, SQAC00642, SQAC00644, SQAC00654, SQAC00655, SQAC00672, SQAC00674, SQAC00675, SQAC00676, SQAC00678, SQAC00684, SQAC00691, SQAC00696, SQAC00726, SQAC00739, SQAC00741, SQAC00758 and 475 more |
Product
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
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-0815-2025. 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.