eSuction Small Cavity (Endo-Therapeutics) – Regulatory Issue (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
eSuction Small Cavity, Model ET2005
Brand
Endo-Therapeutics, Inc.
Lot Codes / Batch Numbers
Model Number: ET2005, UDI-DI: 00816207021393, Lot Numbers: 447037, 447204
Products Sold
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Endo-Therapeutics, Inc. is recalling eSuction Small Cavity, Model ET2005 due to Improper device regulatory classification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Improper device regulatory classification
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, PA
Page updated: Jan 10, 2026