The Recall Desk
HighFDA (Devices)·Z-1096-2026·Announced 2026-01-21

Surgical access port kits recalled over trays that may crack

Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states cracks in the tray may result in a sterility breach, and no injuries are reported.

Plain-English summary

The da Vinci SP Access Port Kit, Large Incision, reference numbers 430073 (2.7-4cm) and 430075 (2.7-7cm), is being recalled by Intuitive Surgical, Inc.

The reason given in the enforcement record is that the Access Port System tray may develop cracks, potentially resulting in a sterility breach.

The record lists 41,526 units, with REF 430073 carrying UDI 00886874119549 and lot numbers listed in the enforcement record. Distribution was worldwide, including nationwide in the United States across Alabama, Arizona, California, Colorado and Connecticut among other states. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should quarantine affected lots and follow Intuitive Surgical's instructions.

The recalled product

Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical access port
Hazard
Affected units
41,526

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

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