Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters
Ethicon Endo-Surgery Inc is recalling 213 Endoscopic Articulating Linear Cutters because a pinion gear failure could interrupt the firing stroke and expose healthcare professionals to sharps injuries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where a sharps injury to healthcare professionals is possible, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 213 units of the Endoscopic Articulating Linear Cutter, model 38ATW35. VASCULAR/THIN 35MM. The device is used in general, gynecologic, urologic, and thoracic surgery for transection, resection, and creation of anastomoses. The affected units were distributed worldwide, including in the United States and internationally to Brazil and Canada.
The recall was initiated after quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples may be formed past the cut line, and the firing stroke may be interrupted. Additionally, the knife may not fully return to the home position, which could potentially expose the healthcare professional to a sharps injury. The device can be opened and removed from the patient if this condition occurs.
Healthcare professionals should stop using the affected devices immediately. The specific lot codes associated with this recall are N91L2N, N91L2P, N91N1J, N91N1K, N91L0T, N91L0U, N91N29, N91N2G, N91R8X, and N91R8Y. Users should contact Ethicon Endo-Surgery Inc for further instructions on how to return the devices.
The recalled product
- Product
- Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 213
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- N91L2N
- N91L2P
- N91N1J
- N91N1K
- N91L0T
- N91L0U
- N91N29
- N91N2G
- N91R8X
- N91R8Y.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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