CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report

Flexible Intubation Fiberscope recalled by Karl Storz Endoscopy

Karl Storz Endoscopy is recalling Flexible Intubation Fiberscope, distributed in 9 states. The recall was initiated on 24 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769

Quantity recalled14 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-2447-2019
FDA event ID: 83419
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2019
FDA classified: 31 Aug 2019
Reported: 11 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Apr 2019	Recall initiated by company
31 Aug 2019	Classified by FDA	+129 days
11 Sep 2019	Published in enforcement report	+11 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 intubation scopes improperly manufactured with a double port luer instead of a single port luer.

Product as listed by the FDA

Flexible Intubation Fiberscope, Model # 11301AB1

Where it was distributed

US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada

California Colorado Louisiana Maine Missouri New Mexico New York Ohio Virginia

Questions about this recall

Why was it recalled?

The action is being initiated due to intubation scopes improperly manufactured with a double port luer instead of a single port luer.

Which lots are affected?

Lot numbers: 2183827, 2195794, 2215741, 2229258, 2235373, 2248169, 2193769

Where was it sold?

US: VA, MO, CA, OH, NM, NY, CO, LA, ME, OUS: Canada

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

More recalls from Karl Storz Endoscopy

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29 Jul 2026Device	CLASS II	Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Sterility	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Sterility	Nationwide
5 Feb 2025Device	CLASS II	Karl Storz - Endoskope recalled	Karl Storz Endoscopy	Sterility	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	Sterility	Nationwide

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