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U.S. Department of Health and Human Services

Class 1 Device Recall Endopath Echelon

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 Class 1 Device Recall Endopath Echelonsee related information
Date Initiated by FirmApril 22, 2025
Date PostedMay 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1746-2025
Recall Event ID 96750
510(K)NumberK141952 
Product Classification Staple, implantable - Product Code GDW
ProductEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Code Information UDI-DI GTIN 10705036014591 Packaging Batches: 917C65 895C93 918C15 938C92 936C69 929C38 948C78 990C81 979C81 400D82 962C74 506D29 379D80 413D56 418D41 419D47 415D43 427D07 434D35 442D78 442D83 444D96 456D87 455D03 493D27 468D88 482D30 502D90 489D62 134D80 112D03 155D33 159D49 181D11 194D77 125D04 167D13 223D59 175D72 234D11 238D70 261D10 270D69 317D74 194D76 349D54 347D73 317D73 356D54 326D66 319D76 338D99 336D39 356D53 367D26 378D04 214D17
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactEthicon Resource Department
877-384-4266
Manufacturer Reason
for Recall		Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
FDA Determined
Cause 2		Device Design
ActionOn April 22, 2025, the firm began to notify affected customers through letters titled, "URGENT: MEDICAL DEVICE CORRECTION." Customers were instructed to notify all users of the affected device and to post a copy of the communication, which reminds users of the Instrument Lockout Instructions that are part of the product IFU. ***UPDATED 8/20/2025*** In May 2025, all customers received an updated letter which stated that Ethicon would also provide in-person training to all impacted US consignees regarding managing a lockout condition.
Quantity in Commerce678,526
DistributionUS distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GDW
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