FDAFDA · Food and drugs·Recall number Z-2174-2017
Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Published June 7, 2017 · Recall initiated: March 31, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a risk that the pinion gear in the device could fail under extreme use cases.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon Endo-Surgery Inc
- Distributor
- Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
- Lot
- N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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