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Unrated Medical device recall · FDA · Published December 19, 2024

Karl Storz Uretero-Renoscope Recall: FDA Unapproved Reprocessing Risks

Karl Storz recalls uretero-renoscope models with unapproved reprocessing methods that may pose safety risks. Affected units include specific lot numbers and CE 0123 marked devices.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1055-2025Medical deviceKarl Storz ›
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Contact the company

Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017
✎ GovInfoNow plain-language explainer

Karl Storz is recalling uretero-renoscope devices that have reprocessing instructions not approved by the FDA. This could lead to safety issues if the devices are reprocessed incorrectly. Read more at govinfonow.com/recall/53207-karl-storz-uretero-renoscope-recall-fda-unapproved-reprocessing-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/53207-karl-storz-uretero-renoscope-recall-fda-unapproved-reprocessing-risks · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1055-2025

Cite this page

“Karl Storz Uretero-Renoscope Recall: FDA Unapproved Reprocessing Risks.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53207-karl-storz-uretero-renoscope-recall-fda-unapproved-reprocessing-risks. Based on FDA recall #Z-1055-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1055-2025%22&limit=1).

The FDA announced on Dec. 19, 2024, that Karl Storz Endoscopy is voluntarily recalling Uretero-Renoscopes because their instructions for use contain unapproved reprocessing modalities. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Karl Storz
  • Product: KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
  • Lot/UDI: 04048551231333
  • Units: 1510

The hazard

The scope's instructions for use include reprocessing modalities that have not been reviewed and/or approved by the FDA for safety and efficacy, according to the agency.

Context

GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since Oct. 10, 2017. Other recent recalls of similar products include Karl Storz HOPKINS Telescope Recall (Aug. 12, 2026), Karl Storz Flexible Hystero-Fiberscope Kits Recall (May 21, 2026), and Karl Storz Endoscopy Optical Biopsy Forceps Recall (Dec. 19, 2024).

How to tell if you have this one

Check for the model number 27010L, uretero-renoscope, 7 Fr., 43cm, non-sterile, RxOnly, and CE 0123 marking. Affected units have specific lot numbers starting with 04048551231333.

  • Brand
    Karl Storz
  • Category
    Medical device
FDA recall event · 14 products

All 14 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1051-2025KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123; All Lots/UDI: 040485512312964 Units
Z-1052-2025KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE; All Lots/UDI: 04048551232095221 units
Z-1053-2025KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE; All Lots/UDI: 04048551232118185 units
Z-1054-2025KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123; All Lots/UDI: 0404855123123439 units
Z-1055-2025KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI: 040485512313331510 units
Z-1056-2025KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI: 0404855131127165 units
Z-1057-2025KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI: 0404855123121059 units
Z-1058-2025KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI: 040485512313715 units
Z-1059-2025KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI:04048551231265102 units
Z-1060-2025KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI:040485512313193069 Units
Z-1061-2025KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI:0404855131081682 units
Z-1062-2025KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI:04048551231227185 units
Z-1063-2025KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123; All Lots/UDI:04048551231227180 units
Z-1064-2025KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123; All Lots/UDI:04048551231357299 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the model number, size, and CE marking to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Dec 19, 202412. FDA classified it Class II: Jan 30, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1055-2025 (December 19, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1055-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA