Karl Storz Endoscopy Recalls Flexible Hystero-Fiberscope Kits
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Karl Storz Endoscopy is recalling 45 Flexible Hystero-Fiberscope Kits that contain expired single-use endoscopic seals, which could impact sterility assurance.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope Kits that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. The kits are indicated for diagnostic and operative hysteroscopic procedures, and the expired seal could impact the assurance of sterility.
Which Products Are Affected
The recall affects 45 units of Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1 distributed nationwide in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. Kit UDI-DI: 04048551226087. Affected 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. The 26153EAU/1 seals have an expiration date of January 23, 2023. Recall number: Z-2794-2026. Classification: Class II.
What You Should Do
Consumers should contact Karl Storz Endoscopy for return or refund instructions regarding the affected kits.
Why This Matters
The recall involves medical devices distributed across multiple U.S. states where the expired seal may compromise sterility during hysteroscopic procedures.
Source
FDA recall Z-2794-2026, Karl Storz Endoscopy, El Segundo, CA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,478 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.