FDA Devices recall · Reported July 29, 2026
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could…
Karl Storz Endoscopy recalled Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single … - a moderate-severity action.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single … was recalled by Karl Storz Endoscopy in July 29, 2026. Reason: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain…. Check the official notice for the remedy. Verify recall #Z-2794-2026 with the FDA Devices before acting.
The recall
Karl Storz Endoscopy issued this moderate-severity FDA Devices recall-Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain….
- Moderate
- severity level
- 45 units
- affected scope
- Class II
- classification
- July 29, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2794-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2794-2026) was formally reported on July 29, 2026, with the manufacturer initiating the action on May 21, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Karl Storz Endoscopy is listed as the recalling firm, operating out of El Segundo, CA. Federal records list the affected scope as 45.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2794-2026 |
| Date reported | July 29, 2026 |
| Date initiated | May 21, 2026 |
| Recalling firm | Karl Storz Endoscopy |
| Firm location | El Segundo, CA |
| Affected scope | 45 |
| Distribution | US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2794-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026