Z-1049-2022Class II

BF-1TQ180: EVIS EXERA II Bronchovideoscope

Name: Z-1049-2022 BF-1TQ180: EVIS EXERA II Bronchovideoscope
Creator: Olympus Corporation of the Americas
Published: 2022-03-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2022-03-08 / Open, Classified / root cause: sterility

FDA source

Olympus Corporation of the Americas began a recall of BF-1TQ180: EVIS EXERA II Bronchovideoscope on 2022-03-08. FDA classified it as Class II and gives the reason as "Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1049-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-08
Posted: 2022-05-06
Recalling firm: OLYMPUS Corporation of the Americas
Product: BF-1TQ180: EVIS EXERA II Bronchovideoscope
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Root cause tag: sterility
FDA root cause: Other
Action: Olympus issued Urgent Medical Device Correction Letters on 3/8/22. Letter states reason for recall, health risk and action to take: 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 a 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 BF-XT160, BF-XP160F, BF-MP160F and BF-3C160 and select the [Download] option. 5. Access the Olympus portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the reference number 0405 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. Contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The TAC department can assist in answering questions on BF-XT160, BF-XP160F, BF-MP160F and BF-3C160 bronchoscope cleaning and reprocessing. " Olympus America has dedicated field personnel, called Endoscopy Support Specialists, who visit customer sites to assess and observe customer reprocessing methods and to
Quantity in commerce: 242 units
Distribution: US Nationwide distribution.
Product codes and lots: All serial numbers. UDI: 04953170339349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1049-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1047-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1048-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1049-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06

Product code EOQ

K061313Class IIEvis Exera 180 SystemOlympus Medical Systems Corporation / cleared 2006-08-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)