FORE-SIGHT ELITE Absolute Tissue Oximeter — Class II medical device recall Z-0834-2022
Ongoing recall by Edwards Lifesciences, LLC, reported 2022-04-06, distributed nationwide. The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the F
| Recall number | Z-0834-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2022-03-01 |
| Classified | 2022-03-30 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CO, CR, CY, CZ, DE, DK, DO, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, VN, ZA |
| Quantity | 402 units |
| UPC / GTIN / UDI-DI | 10609538630009 |
| Model numbers | 01-06-3000 |
Product
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Reason for recall
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
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-0834-2022. 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.