FDA Device recall Z-1776-2020
Medivators EndoGator REF 100650
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Medivators EndoGator REF 100650 by Medivators, citing medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1776-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-09 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medivators |
| Distribution | US |
Product
Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.
Reason
Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Identifiers
| code_info | Lot # / Case UDI#s: 429694 / 2067796406529722070110429694, 429695 / 2067796406529722060110429695, 430357 / 206779…Lot # / Case UDI#s: 429694 / 2067796406529722070110429694, 429695 / 2067796406529722060110429695, 430357 / 2067796406529722070110430357, 430566 / 2067796406529722070110430566, 432106 / 2067796406529722080110432106, 431602 / 2067796406529722070110431602, 431611 / 2067796400000722070110431611, 431972 / 2067796406529722070110431972, 432728 / 2067796406529722080110432728, 431833 / 2067796406529722080110431833, 432920 / 2067796406529722080110432920, 432919 / 2067796406529722080110432919. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2020%22
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