RecallRadar

FDA Device recall Z-0900-2016

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

On 2016-03-02 the FDA classified a Class II recall of Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope by Integrated Medical Systems, citing if excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0900-2016
ClassificationClass II
Statusterminated
Initiated2016-01-20
Published2016-03-02
Last updated2026-09-13 11:54 UTC
CompanyIntegrated Medical Systems
DistributionUS

Product

Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope

Reason

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Identifiers

code_infoSerial Numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325

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-0900-2016%22

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