The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1773-2020·Announced 2020-04-29

Medivators Recalls Endo Smartcap Endoscope Tubing Due to Manufacturing Anomaly

Medivators is recalling Endo Smartcap Endoscope Tubing due to a manufacturing anomaly that may cause inadequate insufflation, air bubbles, or water leaks during endoscopic procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could compromise the safety or efficacy of a procedure (inadequate insufflation, water leaks), but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medivators, Inc. is recalling Endo Smartcap Endoscope Tubing (REF100145CO2) due to a manufacturing anomaly. The affected tubing 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. The product is packaged as Contents 1, 10, and 50 and is found in BMP-C145CO2. It is compatible with Olympus 140/240, 160/260, 180/280, and 190/290 Series Endoscopes.

The recall is being issued because the manufacturing anomaly may present during procedures as inadequate insufflation, the presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

A total of 53,790 units were distributed worldwide, including nationwide distribution in the US and in Australia and England. The affected lot numbers are 426399 and 426401. Users should check their inventory for these specific lot numbers and discontinue use of the affected tubing.

The recalled product

Product
Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a…
Manufacturer
Medivators, Inc.
Category
Medical Device — Endoscopic Accessories
Hazard
Affected units
53,790

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # / UDI #s: 426399 / 006779640594692207241426399
  • 426401 / 006779640594692207241426401.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Medivators, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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