# FDA recall Z-2950-2026

> **Covidien, LLC** · Class II · device recall initiated 2026-05-13.

## 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.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-2950-2026
- **Recalling firm:** Covidien, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-13
- **Report date:** 2026-08-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Clara, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2950-2026

## Citation

> MORVS. FDA recall Z-2950-2026. Retrieved 2026-10-14 from https://api.morvs.ai/recall/Z-2950-2026. Source: US FDA. Licensed CC0.

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