Olympus Bronchovideoscope, Models BF-MP190F recallZ-2497-2023 · Olympus Corporation of the Americas · initiated Jul 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
FDA root cause category: Labeling Change Control
What the company is doing
Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return the provided response form to Sedgwick via email at [email protected] or by fax at 866-552-4917. Any questions about the acknowledgement form may be directed by phone to 866-737-4762. If product has been further distributed, please forward the notification to those secondary consignees and maintain records of your documentation process. Consignees are to report any complaints to Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) and FDA Medwatch. Any further questions are to be directed to Tara Safi by email at [email protected].
Recall details
- Recall number
- Z-2497-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2023
- Posted by the FDA
- Aug 31, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 441 units
- Product code
- EOQ
- FDA submissions
- K172726
- Distribution
- US Nationwide distribution.
Product description
Olympus Bronchovideoscope, Models BF-MP190F.
Code information (models, lots, serial numbers)
UDI-DI: 04953170395581; All Serial Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190FOlympus Medical Systems Corp. · Bronchoscope (flexible or rigid)2 recalls82 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92779).
- Z-2490-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
- Z-2491-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
- Z-2492-2023 · Open, ClassifiedOlympus Bronchovideoscope, Model BF-Q180-AC
- Z-2493-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
- Z-2494-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
- Z-2495-2023 · Open, ClassifiedOlympus Airway Mobilescope, Models MAF-GM & MAF-TM.
- Z-2496-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
- Z-2498-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-XT190.
- Z-2499-2023 · Open, ClassifiedOlympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
- Z-2500-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-P190 & BF-XP190.
- Z-2501-2023 · Open, ClassifiedOlympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
- Z-2502-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-3C40 & BF-N20.
- Z-2503-2023 · Open, ClassifiedOlympus Bronchovideoscope, Models BF-3C160.
- Z-2504-2023 · Open, ClassifiedOlympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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