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Medium risk Medical DevicesClass II

Da Vinci SP Access Port Kit Recall

Da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)

Updated December 15, 2025

Da Vinci SP Access Port Kits (reference numbers 430073 and 430075) may develop cracks in the tray, which could compromise sterility. This is a voluntary recall by Intuitive Surgical.

Is the Intuitive Surgical, Inc. recalled? Yes. This product was recalled by FDA on December 15, 2025. Details below.

What is recalled

Da Vinci SP, SP Access Port Kit, Large Incision, Reference Number 430073 (2.7 to 4 cm, SP1098, Box) and Reference Number 430075 (2.7 to 7 cm, SP1098, Box).

Am I affected

You're affected if you have a da Vinci SP Access Port Kit with reference number 430073 or 430075 on the box label.

What to do right now

Contact Intuitive Surgical, Inc., the manufacturer, immediately to report your kit and receive instructions on the next steps. Do not use the kit if you suspect any damage.

The hazard

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Brands affected

Intuitive Surgical, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1096-2026
Classification
Class II
Recalled
December 15, 2025
Read the official notice

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