n.a. 11264BBU1Recalls & reported problems
Karl Storz GmbH & Co. KG · Hystero-Fiberscope 3.5 mm x 24 cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 21, 2026Open, Classified
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.
Z-2794-2026 · Root cause: Packaging change control · FDA record ↗
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- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.