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Unrated Medical device recall · FDA · Published July 23, 2024

Karl Storz Endoscopy Devices: FDA Safety Review Needed for Reprocessing

Karl Storz recalls endoscopy devices with unapproved reprocessing methods. FDA requires safety review before use. Affected devices include specific models and lots.

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

🇺🇸 FDA recall #Z-3218-2024Medical 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 certain endoscopy devices because their instructions for reprocessing haven't been approved by the FDA for safety and effectiveness. This means the devices could pose risks if used improperly. Read more at govinfonow.com/recall/54572-karl-storz-endoscopy-devices-fda-safety-review-needed-for-reprocessing.

Source Summary by GovInfoNow · govinfonow.com/recall/54572-karl-storz-endoscopy-devices-fda-safety-review-needed-for-reprocessing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3218-2024

Cite this page

“Karl Storz Endoscopy Devices: FDA Safety Review Needed for Reprocessing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54572-karl-storz-endoscopy-devices-fda-safety-review-needed-for-reprocessing. Based on FDA recall #Z-3218-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3218-2024%22&limit=1).

The FDA announced on July 23, 2024, that Karl Storz Endoscopy is recalling the Hopkins Telescope 6 (REF: 27092AMA) because its instructions for use contain unapproved reprocessing modalities. The agency issued recall number Z-3218-2024 for the Class II device.

How to tell if you have it

  • Brand: Karl Storz
  • Product: Karl Storz - Endoskope, REF: 27092AMA, Hopkins Telescope 6
  • UPC: 04048551233344
  • Lot/UDI: (01)04048551233344
  • Units affected: 425

The hazard

According to the FDA, various medical device product instructions for use contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the agency.

Context

GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since October 10, 2017. Other recent recalls of similar products include Karl Storz HOPKINS Telescope Recall (August 12, 2026), Karl Storz Flexible Hystero-Fiberscope Kits (May 21, 2026), and Karl Storz Endoscopy Optical Biopsy Forceps Recall (December 19, 2024). Other recent recalls of similar products include Olympus EVIS EXERA III Duodenoscope Recall (October 14, 2025), Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), and Siemens SOMATOM X.ceed Software Applications Recall (December 19, 2025).

How to tell if you have this one

Check for the model name 'Hopkins Telescope 6' and the lot number (01)04048551233344 on the device. These devices were sold with a CE 0123 marking and require a prescription.

  • Brand
    Karl Storz
  • Product
    Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
  • Category
    Medical device
FDA recall event · 8 products

All 8 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 including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.
Recall numberProduct, codes & lotsQuantity
Z-3218-2024Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123; All Lots/UDI: (01)04048551233344425 units
Z-3219-2024Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123; All Lots/UDI: (01)0404855123336834 units
Z-3220-2024Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123; All Lots/UDI: (01)040485512337711982 units
Z-3221-2024Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123; All Lots/UDI: (01)04048551233795109 UNITS
Z-3222-2024Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123; All Lots/UDI: (01)0404855123379578 units
Z-3223-2024Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123; All Lots/UDI: (01)0404855123385659 UNITS
Z-3224-2024Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123; All Lots/UDI: (01)040485512340995 units
Z-3225-2024Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123; All Lots/UDI: (01)040485513666601 unit
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for the model name 'Hopkins Telescope 6' and lot number (01)04048551233344 on the device.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 49 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jul 23, 202412. FDA classified it Class II: Sep 24, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  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.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this device safe to use?

The recall indicates the reprocessing instructions aren't FDA-approved, so the device may pose risks if reprocessed incorrectly.

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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-3218-2024 (July 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3218-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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