Z-1776-2020Class II

Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with...

Name: Z-1776-2020 Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with...
Creator: Medivators, Inc.
Published: 2019-10-09
License: https://open.fda.gov/license/

Medivators Inc / initiated 2019-10-09 / Terminated / root cause: manufacturing process

FDA source

Medivators, Inc. began a recall of Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II... on 2019-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1776-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-09
Posted: 2020-04-23
Terminated: 2020-12-11
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.
Product code: FAJ Cystoscope And Accessories, Flexible/Rigid
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 53,790 units total
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, England.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1776-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1772-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1773-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1774-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1775-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1776-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1777-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23
Z-1778-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-29	2020-04-23

Product code FAJ

K093665Class IIEndo SmartcapByrne Medical, Inc. / cleared 2009-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)