RecallRadar

FDA Device recall Z-0067-2017

The Introes Pocket Bougie is an endotracheal tube introducer

On 2016-10-19 the FDA classified a Class II recall of The Introes Pocket Bougie is an endotracheal tube introducer by Brathwaites Oliver Medical, citing the Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0067-2017
ClassificationClass II
Statusterminated
Initiated2016-08-19
Published2016-10-19
Last updated2026-09-13 11:54 UTC
CompanyBrathwaites Oliver Medical
DistributionAZ, CT, IL, IN, MA, MO, NC, NE, NY, OH, OR, PA, UT, WI

Product

The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.

Reason

The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.

Identifiers

code_infoModel OL-E12102, lot# 101615.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2017%22

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