Olympus Corporation of the Americas medical device recall: Bronchovideoscope Olympus Bf Type 1T150
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97441
- Recall initiated
- Sep 11, 2025
- Classified by FDA
- Oct 16, 2025
- Posted in Enforcement Report
- Oct 22, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Firm location
- Center Valley, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 23
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 11, 2025. FDA classified it 35 days later, on Oct 16, 2025. This recall event covers 23 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide Distribution. Olympus Corporation of the Americas has 145 recalls in our records.
Recalled products (23)
Z-0045-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Codes / lots: Model No. BF-1T150; UDI: 4953170308185; All Serial No.
Quantity: 3 units US; 1,987 units OUS
Z-0046-2026 Class I Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Codes / lots: Model No. BF-1T180; UDI: 4953170339325; All Serial No.
Quantity: 1,473 units US; 3,774 units OUS
Z-0047-2026 Class I Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Codes / lots: Model No. BF-1T60; UDI: 4953170339264; All Serial No.
Quantity: 347 units US; 2,869 units OUS
Z-0048-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Codes / lots: Model No. BF-1TH1100; UDI: 4953170424199; All Serial No.
Quantity: 0 units US; 1,913 units OUS
Z-0049-2026 Class I Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Codes / lots: Model No. BF-1TH190; UDI: 4953170434778; All Serial No.
Quantity: 4,297 units US; 4,290 units OUS
Z-0050-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Codes / lots: Model No. BF-1TQ170; UDI: 4953170342943; All Serial No.
Quantity: 0 units US; 2,092 units OUS
Z-0051-2026 Class I Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Codes / lots: Model No. BF-1TQ180; UDI: 4953170339349; All Serial No.
Quantity: 215 units US; 736 units OUS
Z-0052-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Codes / lots: Model No. BF-H1100; UDI: 4953170424229; All Serial No.
Quantity: 0 units US; 1,867 units OUS
Z-0053-2026 Class I Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Codes / lots: Model No. BF-H190; UDI: 4953170335174; All Serial No.
Quantity: 5,221 units US; 4,321 units OUS
Z-0054-2026 Class I Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Codes / lots: Model No. BF-MP60; UDI: n/a; All Serial No.
Quantity: 59 units US; 665 units OUS
Z-0055-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Codes / lots: Model No. BF-P150; UDI: 4953170308178; All Serial No.
Quantity: 0 units US; 1,019 units OUS
Z-0056-2026 Class I Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Codes / lots: Model No. BF-P180; UDI: 4953170339288; All Serial No.
Quantity: 1,070 units US; 2,180 units OUS
Z-0057-2026 Class I Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Codes / lots: Model No. BF-P190; UDI: 4953170342110; All Serial No.
Quantity: 3,046 units US; 2,414 units OUS
Z-0058-2026 Class I Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Codes / lots: Model No. BF-P60; UDI: 4953170339196; All Serial No.
Quantity: 1,007 units US; 5,443 units OUS
Z-0059-2026 Class I Ongoing
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Codes / lots: Model No. BF-PE2; UDI: 4953170339974; All Serial No.
Quantity: 2 units US; 4,289 units OUS
Z-0060-2026 Class I Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Codes / lots: Model No. BF-Q170; UDI: 4953170342912; All Serial No.
Quantity: 1 unit US; 2,306 units OUS
Z-0061-2026 Class I Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
Codes / lots: Model No. BF-Q180; UDI: 4953170339301; All Serial No.
Quantity: 665 units US; 2,250 units OUS
Z-0062-2026 Class I Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Codes / lots: Model No. BF-Q180-AC; UDI: 4953170340086; All Serial No.
Quantity: 395 units US; 165 units OUS
Z-0063-2026 Class I Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Codes / lots: Model No. BF-Q190; UDI: 4953170434792, 4953170335198; All Serial No.
Quantity: 916 units US; 1,402 units OUS
Z-0064-2026 Class I Ongoing
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Codes / lots: Model No. BF-TE2; UDI: 4953170339998; All Serial No.
Quantity: 1 unit US; 5,286 units OUS
Z-0065-2026 Class I Ongoing
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Codes / lots: Model No. BF-XT160; UDI: 4953170340147; All Serial No.
Quantity: 262 units US; 558 units OUS
Z-0066-2026 Class I Ongoing
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Codes / lots: Model No. BF-XT190; UDI: 4953170402470; All Serial No.
Quantity: 361 units US; 258 units OUS
Z-0067-2026 Class I Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Codes / lots: Model No. BF-XT40; UDI: n/a; All Serial No.
Quantity: 116 units US; 705 units OUS
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97441
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.