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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95975

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2024
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

14 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 14

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Z-1051-2025
Recall number
Z-1051-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
4 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551231296

Distribution pattern

US Nationwide distribution.

device · product 2 of 14

KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE

Z-1052-2025
Recall number
Z-1052-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
221 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551232095

Distribution pattern

US Nationwide distribution.

device · product 3 of 14

KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE

Z-1053-2025
Recall number
Z-1053-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
185 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551232118

Distribution pattern

US Nationwide distribution.

device · product 4 of 14

KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123

Z-1054-2025
Recall number
Z-1054-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551231234

Distribution pattern

US Nationwide distribution.

device · product 5 of 14

KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123

Z-1055-2025
Recall number
Z-1055-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
1510 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551231333

Distribution pattern

US Nationwide distribution.

device · product 6 of 14

KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Z-1056-2025
Recall number
Z-1056-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
65 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551311271

Distribution pattern

US Nationwide distribution.

device · product 7 of 14

KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Z-1057-2025
Recall number
Z-1057-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551231210

Distribution pattern

US Nationwide distribution.

device · product 8 of 14

KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123

Z-1058-2025
Recall number
Z-1058-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI: 04048551231371

Distribution pattern

US Nationwide distribution.

device · product 9 of 14

KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123

Z-1059-2025
Recall number
Z-1059-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
102 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551231265

Distribution pattern

US Nationwide distribution.

device · product 10 of 14

KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123

Z-1060-2025
Recall number
Z-1060-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
3069 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551231319

Distribution pattern

US Nationwide distribution.

device · product 11 of 14

KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Z-1061-2025
Recall number
Z-1061-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
82 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551310816

Distribution pattern

US Nationwide distribution.

device · product 12 of 14

KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Z-1062-2025
Recall number
Z-1062-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
185 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551231227

Distribution pattern

US Nationwide distribution.

device · product 13 of 14

KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123

Z-1063-2025
Recall number
Z-1063-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551231227

Distribution pattern

US Nationwide distribution.

device · product 14 of 14

KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123

Z-1064-2025
Recall number
Z-1064-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
299 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Code information

All Lots/UDI:04048551231357

Distribution pattern

US Nationwide distribution.