Lower risk Medical device recall · FDA · Published August 27, 2019

Karl Storz Neurofibercope Recall: Incorrect Sterilization Instructions Risk Contamination

Karl Storz recalls flexible pediatric neuroscopes with incorrect sterilization instructions that could lead to contamination if used with SS1E method. Affected models include 11282BN1.

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

🇺🇸 FDA recall #Z-1530-2020Medical device Karl Storz ›

Lower-risk recall

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

Take action

Contact the company

Recalling firmKarl Storz Endoscopy2151 E Grand Ave · El Segundo, CA 90245-5017

✎ GovInfoNow plain-language explainer

Karl Storz is recalling flexible pediatric neuroscopes with model number 11282BN1 due to incorrect sterilization instructions in the manual. This could lead to contamination if users follow the wrong sterilization method. Read more at govinfonow.com/recall/67099-karl-storz-neurofibercope-recall-incorrect-sterilization-instructions-risk-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/67099-karl-storz-neurofibercope-recall-incorrect-sterilization-instructions-risk-contamination · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1530-2020

Cite this page

“Karl Storz Neurofibercope Recall: Incorrect Sterilization Instructions Risk Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67099-karl-storz-neurofibercope-recall-incorrect-sterilization-instructions-risk-contamination. Based on FDA recall #Z-1530-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1530-2020%22&limit=1).

The FDA announced on 2019-08-27 that Karl Storz Endoscopy is recalling its NEURO-FIBERSCOPE, Model # 11282BN1, because the instruction manual contains incorrect sterilization information. This error means sterility cannot be guaranteed if users follow the manual for STERIS System 1E sterilization.

How to tell if you have it

Brand: Karl Storz
Product: NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Lots: All Lots
Quantity: 73 scopes
Distribution: US (AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV) and Canada

The hazard

The FDA said the instruction manual incorrectly specifies Quick Connector Kits (QCK) and tray information for the STERIS System 1E sterilization method. If users rely on this incorrect information to sterilize the scopes, sterility cannot be guaranteed.

Context

GovInfoNow's records show Karl Storz Endoscopy has 24 other recalls on record since 2017-10-10. Recent brand recalls include a 2026-08-12 recall for HOPKINS Telescope due to incorrect eyepiece packaging labels and a 2026-05-21 recall for Flexible Hystero-Fiberscope Kits involving expired sterility seals. Other recent recalls of similar products include Medline Basic Nerve Block Tray Recall (2026-01-07) and Medline Convenience Kits Recall (2026-01-07).

How to tell if you have this one

Check for the model number 11282BN1 on the neuroscope. The recall applies to all lots of this model.

Brand
Karl Storz
Category
Medical device

FDA recall event · 3 products

All 3 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: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda

Recall number	Product, codes & lots	Quantity
Z-1530-2020	Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope; All Lots	73 scopes
Z-1531-2020	Karl Storz, Model # 11161C2, Flexible Neuroscope; All Lots	42 scopes
Z-1532-2020	Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1; All Lots	21 scopes

Based on the official FDA remedy

What to do — step by step

Review Sterilization Instructions
Check the manual for correct sterilization procedures for the STERIS System 1E method.

Where it went and when

Where it was distributed

Distributed in 28 states.

FDA distribution: “US: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NH, NJ, OH, OR, PA, SC, TN, TX, VA, WA, WI, WV, OUS: Canda” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 7 months after the firm started it.

Aug 27, 2019Firm started the recall
Mar 20, 2020FDA classified it Class II
Apr 1, 2020Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/67099-karl-storz-neurofibercope-recall-incorrect-sterilization-instructions-risk-contamination">Karl Storz Neurofibercope Recall: Incorrect Sterilization Instructions Risk Contamination (GovInfoNow)</a>

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-1530-2020 (August 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1530-2020 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.