Fresh Recalls

EndoFLIP System that includes: recall status

Notice names this product. Covidien’s EndoFLIP System that includes is named in FDA Class II recall Z-2950-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Identifying details: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Catheters used after January 1, 2026.. Units affected: 327. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
EndoFLIP System that includes
Company / brand
Covidien
Lot / serial / date codes
ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Catheters used after January 1, 2026.
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.
Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Covidien

Recalls naming this model

FDA Class II · Medical device · August 26, 2026

EndoFLIP System that includes recall — Covidien, LLC

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

Company / brand: Covidien recalls

Affected product: EndoFLIP System that includes recall status

Official ID Z-2950-2026 · Official record ↗

See all Covidien recalls →

Verify with the official sources:

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.