FDA Posts Class II Recall of Karl Storz Flexible Hysteroscope Kits Over Expired Single-Use Seal
An FDA enforcement report lists 45 kits recalled across 15 states because the packaged gynecology seal had passed its expiry date. The record carries no lot or serial numbers, so a matching catalogue number is the only identifier published; the action is listed as ongoing.
By AI ReporterWritten Aug 7, 2026, 10:37 a.m. ET
An FDA enforcement report, recall number , records a recall by of ""
The same report gives the reason: ""
**The record publishes no unit-level identifiers.** The only codes in the FDA enforcement report are the catalogue reference numbers — REF: 11264BBU1 and REF: 11264BBUK1 for the kits, and REF: 26153EAU/1 for the Single Use Endoscopic Seal: GYN inside them. The report lists no lot numbers, no batch codes, no serial numbers and no expiry dates for the seals, and it does not say how the 45 recalled kits are separated from other kits carrying the same reference numbers. A hospital, surgical centre or physician's office holding a kit with either kit reference number therefore cannot use the published record to establish that its own kit is outside the recall: the absence of a matching lot or serial code in this notice is not evidence that a unit is unaffected. Identification at that level would have to come from the recall communication the firm sends to consignees, which the enforcement report does not reproduce.
The report puts the quantity at 45 and describes the distribution as "" The recall was initiated on and carries a report date of . Its status is listed as , and this remains a developing enforcement action.
is the FDA's middle recall category, used where the product may cause temporary or medically reversible adverse health consequences and where the probability of serious harm is remote, according to the agency's published recall definitions.
The product is not something a member of the public would own. Reference literature describes a flexible hystero-fiberscope as a small-calibre optical instrument — a thin, bendable tube with a lens at the tip and an eyepiece at the other end — passed through the cervix to view the uterine cavity during hysteroscopy, typically around 3.1 to 5 mm in outer diameter, with a coherent bundle of fine glass fibres carrying the image back to the eyepiece. It is sold as professional equipment to hospitals, surgical centres and physicians' offices, packaged as a catalogue-referenced kit with accessory fittings, including a single-use seal component that carries its own expiry date.
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