FDAClass IINovember 30, 2022

eSuction Small Cavity recall

eSuction Small Cavity, Model ET2005

Why was eSuction Small Cavity recalled?

Improper device regulatory classification

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204

Product
eSuction Small Cavity, Model ET2005
Recalling firm
Endo-Therapeutics, Inc.
Quantity
28 devices
Distribution
US distribution to Florida and Pennsylvania
Recall date
November 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls