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Medium risk Drugs & MedicationsClass II

Intuitive Surgical, Inc. Recall

Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Updated April 22, 2026

Intuitive Surgical, Inc. is recalling Da Vinci ASSY, PSS, SP1098, Part Number: 380601. Hazard: 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 engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Is the Intuitive Surgical, Inc. recalled? Yes. This product was recalled by FDA on April 22, 2026. Details below.

What is recalled

Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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 engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Brands affected

Intuitive Surgical, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2521-2026
Classification
Class II
Recalled
April 22, 2026
Read the official notice

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