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Recall Observatory FDA recall evidence

Device product

eSuction Small Cavity, Model ET2005

Z-0270-2023

October 24, 2022

Class II

Product summary

Firm
Endo-Therapeutics, Inc.
Event
Event 91074
Status
Terminated
Classification
Class II
Quantity
28 devices
Official record key
device-enforcement:Z-0270-2023

Official wording

Reason: Improper device regulatory classification

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

Distribution pattern: US distribution to Florida and Pennsylvania

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Improper device regulatory classification