Z-2292-2020Class II

ENF-GP2 Rhino-Laryngo Fiberscope -

Name: Z-2292-2020 ENF-GP2 Rhino-Laryngo Fiberscope -
Creator: Olympus Corporation of the Americas
Published: 2020-05-05
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-05-05 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen on 2020-05-05. FDA classified it as Class II and gives the reason as "Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2292-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-05
Posted: 2020-06-08
Terminated: 2020-09-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
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.
FDA root cause: Under Investigation by firm
Action: On May 5, 2020, the firm distributed Urgent Medical Device Corrective Action letters to affected customers. Customers were informed that their endoscopes were incorrectly repaired and may be missing an O-ring in the battery holder. Customers were asked to take the following actions: 1. Immediately cease use of the affected endoscope. Olympus will repair your unit free of charge and provide a replacement loaner until repairs can be completed. 2. An Olympus representative will contact you to make arrangements for return of your affected endoscope. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0171 and provide your contact information as indicated in the portal. If you require additional information, please contact the firm at (484) 896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at [email protected].
Quantity in commerce: 19
Distribution: US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2292-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2292-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-08

Product code EOB

K181240Class IIRhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp. / cleared 2018-10-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)