Flexible Hystero-Fiberscope Kits REF: 11264BBU1 — Class II medical device recall Z-2794-2026
Ongoing recall by Karl Storz Endoscopy, reported 2026-07-29, distributed nationwide. Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain
| Recall number | Z-2794-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 45 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 04048551226087 |
| Serial numbers | 2083136, 2188673, 2215800, 2229591, 2230599, 2236228, 2248338, 2264656, 2267785, 2273282, 2273324, 2273599, 2274041, 2274049, 2274197, 2274198, 2274199, 2274267, 2274269, 2274271, 2275482, 2275483, 2275785, 2275787, 2275788 and 20 more |
| Model numbers | 11264BBU1, 11264BBUK1, 26153EAU/1 |
| Expiration dates | 2023-01-23 |
Product
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2794-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.