DeviceSignal · Recall classified
Covidien, LLC
FDA classified a device recall on 2026-08-14 · Class II · Z-2950-2026
EventRecall classified
Effective2026-08-14
ClassificationClass II
On 2026-08-14 the FDA classified a device recall from Covidien, LLC as Class II. Product: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307…. Recall Z-2950-2026. The firm initiated it on 2026-05-13. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2950-2026
- Classification
- Class II
- Classified on
- 2026-08-14
- Initiated on
- 2026-05-13
- Firm
- Covidien, LLC
- Reason
- The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
- 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.
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2950-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
dd9069426495b0704daa4cc8ea65986167d459af99e47ea5d757396ea6e7b39f- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)