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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88560

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 17, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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

1 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 1

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Z-2497-2021
Recall number
Z-2497-2021
Initiated
August 17, 2021
Classification
Class II
Status
Terminated
Quantity
27 globally (21 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

Code information

1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060

Distribution pattern

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.