Medivators, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1776-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 9, 2019

Date Posted: April 29, 2020

Recall Number: Z-1776-2020

Event ID: 84109

Reason for Recall:

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.

Status: Terminated

Product Quantity: 53,790 units total

Code Information:

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.

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Australia, England.

Voluntary or Mandated:

Voluntary: Firm initiated