Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF:…
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
- Flexible Hystero-Fiberscope Kits REF
11264BBU111264BBUK1that contain
- expired Single Use Endoscopic SealGYN
- REF26153EAU/1
- Lot codes and dates
- Kit UDI-DI04048551226087
- Kit Serial Numbers
227426922732822276217227621622646562275787227975622801542280379227578922834532277877228020422733242275986228348322295912273599221580022741972280156227548320831362275790227548222742712248338228344421886732276221227621722757882274199228344522741982274041228371622740492236228227975722742672275785227789422305992267785. 26153EAU/1
- seals with expiration date
January 232023
- Amount recalled
- 45
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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