Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Brand
Ethicon Endo-Surgery Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Ethicon Endo-Surgery Inc is recalling Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR due to Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026