FDA recall Z-0270-2023
Endo-Therapeutics, Inc. · Class II · device
Product
eSuction Small Cavity, Model ET2005
Reason for recall
Improper device regulatory classification
Distribution
US distribution to Florida and Pennsylvania
Key facts
- Status
- Terminated
- Initiation date
- 2022-10-24
- Report date
- 2022-11-30
- Termination date
- 2024-01-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Clearwater, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0270-2023