Z-2566-2021Class II

BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

Name: Z-2566-2021 BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Creator: Olympus Corporation of the Americas
Published: 2021-08-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-08-16 / Terminated / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of BF-XP60 OES Bronchofiberscope, Model No. BF-XP60 on 2021-08-16. FDA classified it as Class II and gives the reason as "The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2566-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-16
Posted: 2021-09-24
Terminated: 2024-03-11
Recalling firm: OLYMPUS Corporation of the Americas
Product: BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
Product code: EOX Esophagoscope (Flexible Or Rigid)
Reason for recall: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Root cause tag: labeling and UDI
FDA root cause: Reprocessing Controls
Action: On August __, 2021, the firm distributed Urgent Medical Device Corrective Action letters to customers. The applicable addenda to the reprocessing instructions were attached to the letters. Action steps to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after high-level disinfection, and recommendation on using sterilization. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the new reprocessing steps. 4. Additional copies of the new Operation Manuals can be obtained by accessing our OlympusConnect site and downloading a copy of the new Manuals. Please visit our OlympusConnect customer website: at https://www.OlympusConnect.com New users will need to register. Once registered select [Product Support] on the left navigation bar, then select [Instruction Manuals], locate the applicable product codes and select the [Download] option. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. For further information, contact the firm's Technical Assistance Center at 1-800-848-9024, option 1.
Quantity in commerce: 180
Distribution: Domestic distribution nationwide. Product also distributed globally.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2566-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2564-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2565-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2566-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2567-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2568-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2569-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2570-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2571-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2572-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24
Z-2573-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-24

Product code EOX

K023984Class IIModification to Olympus Bronchoscopes Bf-40 Series, Bf-240 Series, and Bf-160 SeriesThe Olympus Optical Co. / cleared 2003-01-31

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)