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FDA Device recall Z-1470-2013

Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars ar…

On 2013-06-12 the FDA classified a Class II recall of Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars ar… by Covidien, citing seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1470-2013
ClassificationClass II
Statusterminated
Initiated2013-05-06
Published2013-06-12
Last updated2026-09-13 11:53 UTC
CompanyCovidien
DistributionUS

Product

Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Reason

Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Identifiers

code_info
Lot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and…Lot Numbers: N2J0211X through N3D0118X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2013%22

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