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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97441

23 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 11, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

23 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

Z-0045-2026
Recall number
Z-0045-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
3 units US; 1,987 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1T150; UDI: 4953170308185; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 2 of 23

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

Z-0046-2026
Recall number
Z-0046-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
1,473 units US; 3,774 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1T180; UDI: 4953170339325; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 3 of 23

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

Z-0047-2026
Recall number
Z-0047-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
347 units US; 2,869 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1T60; UDI: 4953170339264; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 4 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Z-0048-2026
Recall number
Z-0048-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
0 units US; 1,913 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1TH1100; UDI: 4953170424199; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 5 of 23

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Z-0049-2026
Recall number
Z-0049-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
4,297 units US; 4,290 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1TH190; UDI: 4953170434778; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 6 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

Z-0050-2026
Recall number
Z-0050-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
0 units US; 2,092 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1TQ170; UDI: 4953170342943; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 7 of 23

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

Z-0051-2026
Recall number
Z-0051-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
215 units US; 736 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-1TQ180; UDI: 4953170339349; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 8 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Z-0052-2026
Recall number
Z-0052-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
0 units US; 1,867 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-H1100; UDI: 4953170424229; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 9 of 23

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Z-0053-2026
Recall number
Z-0053-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
5,221 units US; 4,321 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-H190; UDI: 4953170335174; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 10 of 23

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

Z-0054-2026
Recall number
Z-0054-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
59 units US; 665 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-MP60; UDI: n/a; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 11 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

Z-0055-2026
Recall number
Z-0055-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
0 units US; 1,019 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-P150; UDI: 4953170308178; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 12 of 23

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

Z-0056-2026
Recall number
Z-0056-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
1,070 units US; 2,180 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-P180; UDI: 4953170339288; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 13 of 23

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Z-0057-2026
Recall number
Z-0057-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
3,046 units US; 2,414 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-P190; UDI: 4953170342110; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 14 of 23

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Z-0058-2026
Recall number
Z-0058-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
1,007 units US; 5,443 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-P60; UDI: 4953170339196; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 15 of 23

BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

Z-0059-2026
Recall number
Z-0059-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
2 units US; 4,289 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-PE2; UDI: 4953170339974; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 16 of 23

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Z-0060-2026
Recall number
Z-0060-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
1 unit US; 2,306 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-Q170; UDI: 4953170342912; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 17 of 23

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

Z-0061-2026
Recall number
Z-0061-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
665 units US; 2,250 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-Q180; UDI: 4953170339301; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 18 of 23

EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Z-0062-2026
Recall number
Z-0062-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
395 units US; 165 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-Q180-AC; UDI: 4953170340086; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 19 of 23

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

Z-0063-2026
Recall number
Z-0063-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
916 units US; 1,402 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-Q190; UDI: 4953170434792, 4953170335198; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 20 of 23

BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Z-0064-2026
Recall number
Z-0064-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
1 unit US; 5,286 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-TE2; UDI: 4953170339998; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 21 of 23

EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Z-0065-2026
Recall number
Z-0065-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
262 units US; 558 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-XT160; UDI: 4953170340147; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 22 of 23

EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Z-0066-2026
Recall number
Z-0066-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
361 units US; 258 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-XT190; UDI: 4953170402470; All Serial No.

Distribution pattern

US Nationwide Distribution.

device · product 23 of 23

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Z-0067-2026
Recall number
Z-0067-2026
Initiated
September 11, 2025
Classification
Class I
Status
Ongoing
Quantity
116 units US; 705 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model No. BF-XT40; UDI: n/a; All Serial No.

Distribution pattern

US Nationwide Distribution.