The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1778-2020·Announced 2020-04-29

Medivators Recalls Endo SmartCap Tubing Due to Manufacturing Anomaly

Medivators is recalling Endo SmartCap Tubing because a manufacturing anomaly 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Medivators, Inc. is recalling the Endo SmartCap Tubing, part of the Endo carry-on Procedure Kit (REF CPK-100222-0002). The recall involves 53,790 units distributed worldwide, including the United States, Australia, and England. The specific lot number is 1000028736, with a GTIN of 00677964086045 and a use-by date of 210120.

The recall is due to a manufacturing anomaly that may present during procedures as inadequate insufflation, the presence of air bubbles inside the tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. The product 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.

Healthcare facilities and consumers should stop using the affected tubing and contact Medivators, Inc. for further instructions on the recall.

The recalled product

Product
Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - 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.
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 (1)

  • Lot # 1000028736 GTIN: 00677964086045 Use-by date: 210120

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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