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n.a.
Karl Storz GmbH & Co. KG · Model 28162BUS · UDI-DI 04048551007648
GWG
Prescription
10
510(k) clearances
283
Adverse events (7 deaths)
22
Recalls
67
Facilities
Description
Clearvision sheath for optic 28162BUA
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-15 | Aesculap Inc | There is the potential for the length of the trocar shaft to be too long. |
| 2025-02-06 | Integra LifeSciences Corp. | Possibility for the obturator to break (separate). |
| 2024-06-07 | Integra LifeSciences Corp. | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
| 2023-07-20 | Aesculap Implant Systems LLC | Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obsc |
| 2019-08-27 | Karl Storz Endoscopy | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) |
| 2019-08-27 | Karl Storz Endoscopy | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) |
| 2019-08-27 | Karl Storz Endoscopy | During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) |
| 2019-02-20 | Karl Storz Endoscopy | The action is being initiated due to Flexible Neuroscopes manufactured with the incorrect channel port. |
| 2017-03-07 | Aesculap Implant Systems LLC | Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when r |
| 2011-12-16 | Geomed Medizin-Technik Gmbh & Co. | The product may fracture during surgical procedures. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.