Endo-Therapeutics eSuction Small Cavity Device Regulatory Misclassification Recall
Endo-Therapeutics is recalling 28 eSuction Small Cavity Model ET2005 devices distributed in Florida and Pennsylvania due to improper regulatory classification.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving improper regulatory classification of a medical device. No adverse events, injuries, hospitalizations, or clinical harms have been reported. The issue is administrative in nature rather than a documented clinical hazard, supporting a Moderate severity assessment.
Plain-English summary
Endo-Therapeutics, Inc. is recalling the eSuction Small Cavity Model ET2005. The recall involves 28 devices that were distributed in the United States to locations in Florida and Pennsylvania. Lot numbers 447037 and 447204 are included in this recall.
The device is being recalled because it was improperly classified under regulatory requirements. No additional details regarding the specific nature of the misclassification have been provided by the manufacturer.
The recalled product
- Product
- eSuction Small Cavity, Model ET2005
- Manufacturer
- Endo-Therapeutics, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: ET2005
- UDI-DI: 00816207021393
- Lot Numbers: 447037
- 447204
Distribution
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