FDA Device recall Z-2950-2026
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 1088452180809…
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 1088452180809… by Covidien, citing the system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2950-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-13 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Covidien |
| Distribution | US |
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
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
Identifiers
| code_info | ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 0539…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Covidien
- V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0…
FDA Device · Class II · 2026-08-19 · Covidien - V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2…
FDA Device · Class II · 2026-08-19 · Covidien - Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
FDA Device · Class II · 2026-08-19 · Covidien - Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
FDA Device · Class II · 2026-08-19 · Covidien - Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
FDA Device · Class II · 2026-08-19 · Covidien
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2950-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.