EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100… — Class II medical device recall Z-2950-2026
Ongoing recall by Covidien, LLC, reported 2026-08-26, distributed nationwide. The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable
| Recall number | Z-2950-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LLC, Santa Clara, CA, United States |
| Recall initiated | 2026-05-13 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CO, CR, DE, DK, ES, FR, GB, HK, IE, IL, IT, KR, NL, NO, NZ, PT, SE |
| Quantity | 327 |
| UPC / GTIN / UDI-DI | 05391530810050, 05391530810166, 10884521786684, 10884521808096, 10884521809307 |
Product
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
Reason for recall
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
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-2950-2026. 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.