FDA Medical Device Recalls (openFDA)
Medivators, Inc.: 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.
- Recall number
- Z-1776-2020
- Recalling firm
- Medivators, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2019-10-09
- Posted
- not on file
- Terminated
- 2020-12-11
- 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.
- Root cause
- Equipment maintenance
- Action
- An Urgent Medical Device Recall Notification letter was sent to customers via certified mail next day delivery on 10/09/2019. The letter identified affected product, stated reason for recall, asked for product to be quarantined and discontinue use. Customers are to return product to Medivators by obtaining a Return Material Authorization from Customer Service. A response form was asked to be returned. Questions can be directed to Customer Service at 1-800-444-4729.
- Quantity
- 53,790 units total
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K093665"]
- PMA numbers
- not on file
- Product code
- FAJ
- Firm FEI
- 2150060
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28