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Lower risk Medical device recall · FDA · Published April 6, 2023

Karl Storz Metal Sterilization Trays Recall: New 510(k) Instructions

Karl Storz recalls specific metal sterilization trays due to new 510(k) instructions for use that may require updated sterilization methods. Affected trays have unique dimensions and reference numbers.

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

🇺🇸 FDA recall #Z-1991-2023Medical 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 several metal sterilization trays because their new 510(k) instructions for use may not be fully compatible with standard sterilization processes. This could lead to improper sterilization if not followed correctly. Read more at govinfonow.com/recall/58599-karl-storz-metal-sterilization-trays-recall-new-510-k-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/58599-karl-storz-metal-sterilization-trays-recall-new-510-k-instructions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1991-2023

Cite this page

“Karl Storz Metal Sterilization Trays Recall: New 510(k) Instructions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58599-karl-storz-metal-sterilization-trays-recall-new-510-k-instructions. Based on FDA recall #Z-1991-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1991-2023%22&limit=1).

The FDA announced on April 6, 2023, that Karl Storz Endoscopy is recalling metal and wire sterilization trays due to labeling issues. The company initiated the voluntary Class II recall affecting approximately 4,933 units distributed worldwide.

How to tell if you have it

  • Brand: Karl Storz
  • Metal Tray, 178 x 135 x 37 mm, REF: 11580A
  • Metal Tray, 275 x 178 x 35 mm, REF: 11580B
  • Metal Tray, 373 x 178 x 35 mm, REF: 11580C
  • Metal Tray, 275 x 175 x 37 mm, REF: 11580D
  • Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1
  • Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2
  • Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2
  • Wire Tray for ENDOCAMELEON, REF: 39501BEC
  • Tray, with lid, 670x80x52mm, REF: 39501C
  • Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC
  • Wire Tray Retromolar Intub. Endoscope, REF: 39501F
  • Wire basket for c-mac videolaryngoscope, REF: 39501LC2
  • Tray, URS, 644 x 150 x 80 mm, REF: 39501X
  • Wire Tray, URS, REF: 39501XK
  • Wire tray PECD, REF: 39501XP
  • Tray, paranasal sinus shaver system, REF: 39550A

The hazard

The recall addresses metal sterilization trays that have a new 510(k) with instructions for use specific to the tray models. This labeling includes information regarding the sterilization modality.

Context

GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since October 10, 2017. Recent brand recalls include a May 21, 2026, recall of Flexible Hystero-Fiberscope Kits for expired sterility seal risk and a December 19, 2024, recall of Optical Biopsy Forceps for sterility risk. Other recent recalls of similar products include the January 7, 2026, Medline Basic Nerve Block Tray Recall and the June 1, 2026, Argon Medical Devices One-Piece Introducer Tray Recall.

How to tell if you have this one

Check for trays with dimensions listed in the recall: 178x135x37mm (REF: 11580A), 275x178x35mm (REF: 11580B), or 373x178x35mm (REF: 11580C). Also look for reference numbers like 39501A1 or 39501BEC.

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

What to do — step by step

  1. Check Product Details

    Review the tray's dimensions and reference numbers to confirm if it is affected by this recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: 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 noticeFL

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

Named in the notice: Alabama, Alaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Apr 6, 202312. FDA classified it Class II: Jun 21, 202323. Published in FDA’s Enforcement Report: Jun 28, 202332023
  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-1991-2023 (April 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1991-2023 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