Recall archive / FDA device enforcement
eSuction Small Cavity, Model ET2005 — FDA record Z-0270-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- eSuction Small Cavity, Model ET2005
- Reason
- Improper device regulatory classification
- Classification
- Class II
- Recalling firm
- Endo-Therapeutics, Inc.
- Quantity
- 28 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-0270-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Florida and Pennsylvania
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 30, 2022
- Recall initiation date
- Oct 24, 2022
- Center classification date
- Nov 18, 2022
- Termination date
- Jan 24, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.