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Flexible Hystero-Fiberscope Kits
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MEDICAL DEVICE RECALLMODERATE

Flexible Hystero-Fiberscope Kits

Karl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.

What to do

Check your inventory for Flexible Hystero-Fiberscope Kits with REF 11264BBU1 or 11264BBUK1. If the kit contains an expired Single Use Endoscopic Seal (REF 26153EAU/1), stop using it immediately and contact Karl Storz Endoscopy for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
Z-2794-2026
Agency
FDA
Firm
Karl Storz Endoscopy
Recall ID
99027
Status
ONGOING

Why it was recalled

Karl Storz Endoscopy is recalling Flexible Hystero-Fiberscope Kits (REF: 11264BBU1, 11264BBUK1) because they contain an expired Single Use Endoscopic Seal (REF: 26153EAU/1). The expired seal may compromise sterility assurance during diagnostic and operative hysteroscopic procedures.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

UDI-DI
04048551226087

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Sterility Failure recalls

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Editorial summary by Recall Canary · summary updated 2026-07-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification