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U.S. Department of Health and Human Services

Class 2 Device Recall eSuction

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  Class 2 Device Recall eSuction see related information
Date Initiated by Firm October 24, 2022
Date Posted November 18, 2022
Recall Status1 Terminated 3 on January 24, 2024
Recall Number Z-0270-2023
Recall Event ID 91074
Product Classification Snare, non-electrical - Product Code FGX
Product eSuction Small Cavity, Model ET2005
Code Information Model Number: ET2005; UDI-DI: 00816207021393; Lot Numbers: 447037, 447204
Recalling Firm/
Manufacturer		 Endo-Therapeutics, Inc.
15201 Roosevelt Blvd Ste 104
Clearwater FL 33760-3559
For Additional Information Contact Debbie Reed
727-538-9570
Manufacturer Reason
for Recall		 Improper device regulatory classification
FDA Determined
Cause 2		 Other
Action Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form.
Quantity in Commerce 28 devices
Distribution US distribution to Florida and Pennsylvania
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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