CLASS II Device recall · Reported 4 Sep 2019 · FDA Enforcement Report

Flexible Neuro-fiberscope recalled by Karl Storz Endoscopy

Karl Storz Endoscopy is recalling Flexible Neuro-fiberscope, distributed in 13 states. The recall was initiated on 20 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

Quantity recalled22 scopes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2425-2019
FDA event ID: 83459
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Feb 2019
FDA classified: 28 Aug 2019
Reported: 4 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Feb 2019	Recall initiated by company
28 Aug 2019	Classified by FDA	+189 days
4 Sep 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Product as listed by the FDA

FLEXIBLE NEURO-FIBERSCOPE, 3.7MM X 34CM, Model # 11282BN1

Where it was distributed

US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

Alabama California Florida Massachusetts Michigan Missouri North Carolina New Hampshire Ohio Oregon Pennsylvania Virginia Washington

Questions about this recall

Why was it recalled?

The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port.

Which lots are affected?

SERIAL NUMBER: 2161516, 2204079, 2172240, 2198276, 2062041, 2178784, 2198341, 2220959, 2210200, 2183837, 2188370, 2247464, 2248783, 2194154, 2244117, 2039298

Where was it sold?

US: FL, MO, MA, AL,CA, OH, PA,NH, OR, WA, MI, NC, CA, VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Other	Nationwide

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