Endopath ETS-FLEX Endoscopic Articulating Linear Cutter recall
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Why was Endopath ETS-FLEX Endoscopic Articulating Linear Cutter recalled?
There is a risk that the pinion gear in the device could fail under extreme use cases.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
- Product
- Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 792 units
- Distribution
- Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
- Recall date
- June 7, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)