CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy

Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope Kits, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.

Quantity recalled45

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-2794-2026
FDA event ID: 99027
Recalling firm: Karl Storz Endoscopy, El Segundo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 May 2026
FDA classified: 23 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Surgical Instruments

Timeline

21 May 2026	Recall initiated by company
23 Jul 2026	Classified by FDA	+63 days
29 Jul 2026	Published in enforcement report	+6 days

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

Reason for recall

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.

Where it was distributed

US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.

Nationwide California Florida Georgia Louisiana Massachusetts Maryland Michigan Minnesota New York Ohio Pennsylvania Texas Virginia Vermont Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785. 26153EAU/1 seals with expiration date: January 23, 2023.

Where was it sold?

US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.

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.

More recalls from Karl Storz Endoscopy

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

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