Z-0688-2024Class II

Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

Name: Z-0688-2024 Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Creator: Shirakawa Olympus Co., Ltd.
Published: 2023-12-04
License: https://open.fda.gov/license/

Shirakawa Olympus Co., Ltd. / initiated 2023-12-04 / Open, Classified / root cause: labeling and UDI

FDA source

Shirakawa Olympus Co., Ltd. began a recall of Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE on 2023-12-04. FDA classified it as Class II and gives the reason as "Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0688-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-04
Posted: 2024-01-09
Recalling firm: Shirakawa Olympus Co., Ltd.
Product: Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
Product code: EOB Nasopharyngoscope (Flexible Or Rigid)
Reason for recall: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version. The most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. Once registered select the Product Support button on the left navigation bar, select the [Reprocessing Manuals] button, locate the BF-P190 and BF-XP190 Instructions for Use and select the [Download] button. If you require additional information, please contact the firm directly by phone at (647) 999-3203 or by e-mail at [email protected]
Quantity in commerce: 1929 US; 2200 OUS
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170059018 All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0688-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0684-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0685-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0686-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0687-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0688-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0689-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0690-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0691-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09
Z-0692-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-09

Product code EOB

K221660Class IIRhino-Laryngofiberscope Olympus Enf Type-XpOlympus Medical Systems Corp. / cleared 2022-12-28

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)