Severity
Moderate
FDA Devices recall · Reported October 10, 2018
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrume…
Olympus Corporation of the Americas recalled Bronchovideoscope BF-P180 - a moderate-severity action.
Bronchovideoscope BF-P180 was recalled by Olympus Corporation of the Americas in October 10, 2018. Reason: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in …. Check the official notice for the remedy. Verify recall #Z-3297-2018 with the FDA Devices before acting.
The recall
Olympus Corporation of the Americas issued this moderate-severity FDA Devices recall-The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-3297-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-3297-2018) was formally reported on October 10, 2018, with the manufacturer initiating the action on August 8, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Olympus Corporation of the Americas is listed as the recalling firm, operating out of Center Valley, PA. Federal records list the affected scope as 3705.
The documented reason for this recall is: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. Distribution data in the federal record shows the product reached: The products were distributed US nationwide and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
3705
Related Recalls
6
0 from same agency
Bronchovideoscope BF-P180
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3297-2018 |
| Date reported | October 10, 2018 |
| Date initiated | August 8, 2018 |
| Recalling firm | Olympus Corporation of the Americas |
| Firm location | Center Valley, PA |
| Affected scope | 3705 |
| Distribution | The products were distributed US nationwide and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 10, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.