FDA Medical Device Recalls (openFDA)
Endo-Therapeutics, Inc.: eSuction Small Cavity, Model ET2005
- Recall number
- Z-0270-2023
- Recalling firm
- Endo-Therapeutics, Inc.
- Product
- eSuction Small Cavity, Model ET2005
- Status
- Terminated
- Initiated
- 2022-10-24
- Posted
- 2022-11-18
- Terminated
- 2024-01-24
- Reason
- Improper device regulatory classification
- 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
- 28 devices
- Distribution
- US distribution to Florida and Pennsylvania
- Lot, serial or model codes
- Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGX
- Firm FEI
- 1000132436
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28