Endo-Therapeutics recalls eSuction Small Cavity Model ET2:005 due to improper regulatory classification. Affected units include specific lot numbers and model. No immediate action required as the hazard is not a safety risk.
Improper device regulatory classification
Endo-Therapeutics is recalling their eSuction Small Cavity Model ET2005 due to improper regulatory classification. This issue does not pose a safety risk to users and does not require immediate action.
The device has an improper regulatory classification, meaning it may not meet the required standards for its intended use. However, this classification issue does not cause physical harm or safety risks during normal use.
Users of the eSuction Small Cavity Model ET2005 with lot numbers 447037 or 447204 are affected. This recall does not pose a safety risk to users.
Check for the model number ET2005 on the device. Affected units have lot numbers 447037 or 447204. The device may also have a unique identifier (UDI-DI) of 00816207021393.
Verify the model number is ET2005 and lot number is 447037 or 447204.
No, the recall is for improper regulatory classification but does not pose a safety risk.
No, the recall does not require stopping use as it is not a safety hazard.
Check the model number and lot number to confirm if it's affected. No action is needed if it's not in the recall list.
We’ve drafted a message you can send Endo-Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall Z-0270-2023 — Endo-Therapeutics Endo-Therapeutics Hello, I own a Endo-Therapeutics that is covered by recall Z-0270-2023 from Endo-Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
