CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report

ENF-GP2 Rhino-Laryngo Fiberscope recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling ENF-GP2 Rhino-Laryngo Fiberscope, distributed nationwide in the US. The recall was initiated on 5 May 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 2901130 2901567 2901655 2901548 7900416 7900638 7900546 7900590 2901700 2901410 2901456 2901451 2901414 2901435 2901428 2901437 2901624 2901753 2901788 2801008 2801059 2801069 2801072 2801046 2801023 2901343 2801076 2801010 2801009 2801019 2901891 7900545 2801059 TEST1 TEST2 2801072 7900644 2901529 2801051 7900360 7900187 7900362 7900542 7900589 2801008 7900264 2801058 2801007 2801012 7900612

Quantity recalled19

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2292-2020
FDA event ID: 85621
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2020
FDA classified: 8 Jun 2020
Reported: 17 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 May 2020	Recall initiated by company
8 Jun 2020	Classified by FDA	+34 days
17 Jun 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

Product as listed by the FDA

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

Where it was distributed

US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.

Nationwide Florida Michigan New Mexico New York Ohio Oregon

Questions about this recall

Why was it recalled?

Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

Which lots are affected?

Serial Numbers 2901130 2901567 2901655 2901548 7900416 7900638 7900546 7900590 2901700 2901410 2901456 2901451 2901414 2901435 2901428 2901437 2901624 2901753 2901788 2801008 2801059 2801069 2801072 2801046 2801023 2901343 2801076 2801010 2801009 2801019 2901891 7900545 2801059 TEST1 TEST2 2801072 7900644 2901529 2801051 7900360 7900187 7900362 7900542 7900589 2801008 7900264 2801058 2801007 2801012 7900612

Where was it sold?

US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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