Ethicon Endo-Surgery Recalls Endoscopic Articulating Linear Cutters Due to Gear Failure
Ethicon Endo-Surgery Inc is recalling 105 Endoscopic Articulating Linear Cutters because a pinion gear could fail, potentially causing a sharps injury to healthcare professionals.
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 medical device with a potential risk of sharps injury to healthcare professionals, but no injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 105 units of the Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The device is used in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. The affected lots are identified by the codes N91L48, N91L49, N91R40, N91R41, N91U0W, and N91U0X.
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 potentially exposes the healthcare professional to a sharps injury. The device can be opened and removed from the patient if this failure occurs.
The affected units were distributed worldwide, including in the United States (AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI) and internationally to Brazil and Canada. Healthcare professionals should stop using the affected devices and contact Ethicon Endo-Surgery Inc for further instructions.
The recalled product
- Product
- Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. 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
- 105
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 (6)
- N91L48
- N91L49
- N91R40
- N91R41
- N91U0W
- N91U0X
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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