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Lower risk Medical device recall · FDA · Published August 12, 2026

Karl Storz HOPKINS Telescope Recall: Incorrect Eyepiece Packaging Label

Karl Storz recalls HOPKINS Telescope 30°, 4mm REF 10005BA models with UDI-DI code 04048551045121 due to incorrect inside packaging label for eyepiece. Affected units sold in AZ, CA, MO.

🇺🇸 FDA recall #Z-3333-2026Medical deviceKarl Storz ›
✎ GovInfoNow plain-language explainer

Karl Storz is recalling HOPKINS Telescope 30°, 4mm REF 10005BA models with specific UDI-DI code and serial numbers due to an incorrect inside packaging label for the eyepiece. This issue does not pose a safety risk but requires correction to ensure proper labeling. Read more at govinfonow.com/recall/1449370-karl-storz-endoscopy-recalls-hopkins-telescope-30-4mm-ref-10005ba.

Source Summary by GovInfoNow · govinfonow.com/recall/1449370-karl-storz-endoscopy-recalls-hopkins-telescope-30-4mm-ref-10005ba · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3333-2026

Cite this page

“Karl Storz HOPKINS Telescope Recall: Incorrect Eyepiece Packaging Label.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449370-karl-storz-endoscopy-recalls-hopkins-telescope-30-4mm-ref-10005ba. Based on FDA recall #Z-3333-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3333-2026%22&limit=1).

The FDA announced on August 12, 2026, that Karl Storz Endoscopy is recalling HOPKINS Telescope 30¿, 4mm REF 10005BA and HOPKINS¿ II telescopes due to incorrect inside packaging labels for the eyepiece. This Class II recall affects units distributed nationwide in Arizona, California, and Missouri.

How to tell if you have it

  • Brand: Karl Storz
  • Product: HOPKINS Telescope 30¿, 4mm REF 10005BA
  • UDI-DI code: 04048551045121
  • Product: KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes
  • Material Number: 10005BA
  • Serial Numbers: 100011, 100012, 10000Y, and 10000Z

The hazard

The recall is due to an incorrect inside packaging label for the eyepiece on the HOPKINS Telescope 30¿, 4mm REF 10005BA. The telescopes are intended for visualization of the surgical site during diagnostic and therapeutic endoscopic procedures.

Context

GovInfoNow's records show Karl Storz Endoscopy has issued 24 other recalls since October 10, 2017. Recent brand recalls include a May 21, 2026 recall for Flexible Hystero-Fiberscope Kits regarding expired sterility seals and December 19, 2024 recalls for Pediatric Cysto-Urethroscopes and Optical Biopsy Forceps concerning unapproved reprocessing and sterility risks. Other recent recalls of similar products include a Covidien Shiley Tracheostomy Tube recall (April 15, 2026) and a Baxter Healthcare PRO+ 40" MRS SURFACE Mattress recall (August 18, 2026).

How to tell if you have this one

Check for the model HOPKINS Telescope 30°, 4mm REF 10005BA with UDI-DI code 04048551045121 and serial numbers 100011, 100012, 10000Y, or 10000Z. These units were distributed in Arizona, California, and Missouri.

  • Brand
    Karl Storz
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the UDI-DI code 04048551045121 and serial numbers 100011, 100012, 10000Y, or 10000Z on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA and MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Missouri.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Aug 12, 202612. FDA classified it Class II: Sep 30, 202623. Published in FDA’s Enforcement Report: Oct 7, 202634. Added to GovInfoNow: Oct 13, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

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-3333-2026 (August 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3333-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 14, 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