Olympus Corporation Of The Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Reason for recall
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Lot / code information
- Model
- BF-MP60
- UDI
- n/a; All
What the firm is doing
An URGENT Medical Device Correction notification dated 9/11/25 was mailed to consignees to notify them of this recall action. Consignees are asked to carefully read the recall notification and identify any affected devices in their inventory. Consignees are to ensure all personnel are knowledgeable and aware of the updated IFU. Consignees are to acknowledge receipt of the recall notification through Olympus' web portal at https://olympusamerica.com/recall. Forward the provided recall notification if product was further distributed. Consignees with any questions can contact Cynthia Ow by phone at 647-999-3203 or by email at Cynthia.Ow@olympus.com.
DistributionShow detailsHide
US Nationwide Distribution.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0054-2026
- FDA 510(k) clearance · K023984The device's official FDA premarket clearance record
- FDA device classification · EOQOfficial FDA classification for this device type
- CFR regulation · 21 CFR 874.4680The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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