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Recall

Class II — Ethicon Endo-Surgery Inc

Recalling firmETHICON ENDO-SURGERY, INC.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThere is a risk that the pinion gear in the device could fail under extreme use cases.
ProductEndopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
Quantity792 units
DistributionWorldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
Initiated2017-03-31
Classified2017-05-31
Terminated2018-05-03
Recall numberZ-2174-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Ethicon Endo-Surgery Inc (Z-2174-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76921/

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