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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89881

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

Open FDA event record

Event summary

Timeline bucket
April 01, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Karl Storz Endoscopy

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

2 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 2

11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018)

Z-1054-2022
Recall number
Z-1054-2022
Initiated
April 01, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
All Serial Numbers manufactured/distributed since January 2018

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

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

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Code information

11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0 (10-2018) UDI Code: 0408551225608 All Serial Numbers manufactured/distributed since January 2018

Distribution pattern

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.

device · product 2 of 2

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Z-1055-2022
Recall number
Z-1055-2022
Initiated
April 01, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
All Serial Numbers manufactured/distributed since January 2018

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

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

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

Code information

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

Distribution pattern

U.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC, NH, NJ, OK, SC, TX and WA.