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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89942

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

Open FDA event record

Event summary

Timeline bucket
March 08, 2022
Product types
Device
Classifications
Class II
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

4 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 4

BF-MP60: OES Bronchofiberscope

Z-1046-2022
Recall number
Z-1046-2022
Initiated
March 08, 2022
Classification
Class II
Status
Ongoing
Quantity
60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Code information

All serial numbers. UDI: 04953170339394

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

BF-3C160: EVIS EXERA Bronchovideoscope

Z-1047-2022
Recall number
Z-1047-2022
Initiated
March 08, 2022
Classification
Class II
Status
Ongoing
Quantity
1052 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Code information

All serial numbers. UDI: 04953170340031

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

BF-MP160F: EVIS EXERA Bronchofibervideoscope

Z-1048-2022
Recall number
Z-1048-2022
Initiated
March 08, 2022
Classification
Class II
Status
Ongoing
Quantity
292 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Code information

All serial numbers. UDI: 04953170289064

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

BF-1TQ180: EVIS EXERA II Bronchovideoscope

Z-1049-2022
Recall number
Z-1049-2022
Initiated
March 08, 2022
Classification
Class II
Status
Ongoing
Quantity
242 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Code information

All serial numbers. UDI: 04953170339349

Distribution pattern

US Nationwide distribution.