Flexible Hystero-Fiberscope Kits REF: recall status

Notice names this product. Karl Storz Endoscopy’s Flexible Hystero-Fiberscope Kits REF is named in FDA Class II recall Z-2794-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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.. Units affected: 45. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Flexible Hystero-Fiberscope Kits REF
Company / brand: Karl Storz Endoscopy
Lot / serial / date codes: 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.
Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Karl Storz Endoscopy

Recalls naming this model

FDA Class II · Medical device · July 29, 2026

Flexible Hystero-Fiberscope Kits REF recall — Karl Storz Endoscopy

Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could …

Company / brand: Karl Storz Endoscopy

Affected product: Flexible Hystero-Fiberscope Kits REF

Official ID Z-2794-2026 · Official record ↗

See all Karl Storz Endoscopy recalls →

Verify with the official sources:

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.