Z-2012-2023Class I

Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

Name: Z-2012-2023 Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Creator: Olympus Corporation of the Americas
Published: 2023-06-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-06-08 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 on 2023-06-08. FDA classified it as Class I and gives the reason as "There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2012-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-06-08
Posted: 2023-07-17
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
Product code: EOQ Bronchoscope (Flexible Or Rigid)
Reason for recall: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
FDA root cause: Under Investigation by firm
Action: An "URGENT MEDICAL DEVICE CORRECTIVE ACTION" notification letter dated 6/8/23 was sent to customers. Actions to be taken by the company: The labelling will be updated to include specificity about laser compatibility, improved instructions regarding patient preparation, and warnings about patient injury and death resulting from incompatible laser use. Actions to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names. 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 compatible laser type. 3. Ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0427 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Olympus requests that you report complaints, including any injuries associated with laser procedures with Olympus bronchoscopes, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Olympus regrets any inconvenience caused and fully appreciates your cooperation in this matter. Please do not hesitate to call (647) 999-3203 or email: at [email protected] for any additional information or support concerning this matter.
Quantity in commerce: 4 units
Distribution: US Nationwide Distribution.
Product codes and lots: All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2012-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2011-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2012-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2013-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2014-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2015-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2016-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17
Z-2017-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17

Product code EOQ

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