Medivators EndoGator REF 100650 — Class II medical device recall Z-1776-2020
Terminated recall by Medivators, Inc., reported 2020-04-29, distributed nationwide. Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures
| Recall number | Z-1776-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medivators, Inc., Plymouth, MN, United States |
| Recall initiated | 2019-10-09 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB |
| Quantity | 53,790 units |
| Reason classes | packaging |
| Model numbers | 100650 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1776-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.