CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
eSuction Small Cavity recalled by Endo-Therapeutics
Endo-Therapeutics is recalling eSuction Small Cavity, distributed in Florida, Pennsylvania. The recall was initiated on 24 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0270-2023
- FDA event ID
- 91074
- Recalling firm
- Endo-Therapeutics, Clearwater, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2022
- FDA classified
- 18 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Oct 2022 | Recall initiated by company | |
| 18 Nov 2022 | Classified by FDA | +25 days |
| 30 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Improper device regulatory classification
Product as listed by the FDA
eSuction Small Cavity, Model ET2005
Where it was distributed
US distribution to Florida and Pennsylvania
Questions about this recall
Is eSuction Small Cavity recalled?
Yes. Endo-Therapeutics recalled eSuction Small Cavity on 24 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0270-2023.
Why was it recalled?
Improper device regulatory classification
Which lots are affected?
Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Where was it sold?
US distribution to Florida and Pennsylvania
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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