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Sterile Set
Aktormed GmbH · Model 171907 · UDI-DI 04260463849073
NAY
Prescription
10
510(k) clearances
143,877
Adverse events (800 deaths)
248
Recalls
96
Facilities
Description
consisting of - 1x Endoscope clamp (141363) - 1x Universal joint (141362) - 1x Tension sleeve D10 (141339) - 1x Tension sleeve D5 (141365) - 1x Sterilization tray (141357)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Intuitive Surgical, Inc. | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching fro |
| 2026-04-22 | Intuitive Surgical, Inc. | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engage |
| 2026-04-02 | Intuitive Surgical, Inc. | Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. |
| 2026-03-11 | Intuitive Surgical, Inc. | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
| 2025-12-30 | Intuitive Surgical, Inc. | Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maint |
| 2025-12-15 | Intuitive Surgical, Inc. | Access Port System tray may develop cracks potentially resulting in a sterility breach. |
| 2025-12-09 | Intuitive Surgical, Inc. | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| 2025-12-09 | Intuitive Surgical, Inc. | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| 2025-12-09 | Intuitive Surgical, Inc. | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| 2025-12-09 | Intuitive Surgical, Inc. | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
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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.