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n.a.
Karl Storz GmbH & Co. KG · Model 27085PK · UDI-DI 04048551079751
FEO
Prescription
10
510(k) clearances
1,213
Adverse events (4 deaths)
7
Recalls
20
Facilities
Description
Protection Tube for Sterilization
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-08 | Olympus Corporation of the Americas | Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electroma |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/ |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/ |
| 2025-11-14 | Olympus Corporation of the Americas | Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/ |
| 2025-10-08 | Olympus Corporation of the Americas | The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer h |
| 2022-07-07 | Olympus Corporation of the Americas | Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electroma |
| 2020-04-23 | Olympus Corporation of the Americas | A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization. |
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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.