Z-0270-2023Class II

eSuction Small Cavity, Model ET2005

Name: Z-0270-2023 eSuction Small Cavity, Model ET2005
Creator: Endo-Therapeutics, Inc.
Published: 2022-10-24
License: https://open.fda.gov/license/

Endo-Therapeutics, Inc. / initiated 2022-10-24 / Terminated

FDA source

Endo-Therapeutics, Inc. began a recall of eSuction Small Cavity, Model ET2005 on 2022-10-24. FDA classified it as Class II and gives the reason as "Improper device regulatory classification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0270-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-24
Posted: 2022-11-18
Terminated: 2024-01-24
Recalling firm: Endo-Therapeutics, Inc.
Product: eSuction Small Cavity, Model ET2005
Product code: FGX Snare, Non-Electrical
Reason for recall: Improper device regulatory classification
FDA root cause: Other
Action: Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form.
Quantity in commerce: 28 devices
Distribution: US distribution to Florida and Pennsylvania
Product codes and lots: Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0270-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0270-2023	Class II	Terminated	Voluntary: Firm initiated	2022-11-30	2022-11-18

Product code FGX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)