Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1048-2015·Announced 2015-02-11

Intuitive Surgical Recalls da Vinci Si Wall Charts for Sterilization Inconsistency

Intuitive Surgical is recalling 1,034 da Vinci Si Wall Charts because they contained incorrect sterilization dry time information inconsistent with the User Manual.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a documentation inconsistency regarding sterilization dry time, which is a procedural error rather than a direct physical defect or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Intuitive Surgical, Inc. is recalling 1,034 units of the Wall chart for the EndoWrist Stapler 45 System, intended for use with the da Vinci Si Surgical System (IS3000). The affected wall charts are identified by part numbers PN 410298-05, -06, -07, -08, and -09. These products were distributed nationwide.

The recall was initiated because the wall charts were found to be inconsistent with the User Manual Addendum regarding the necessary sterilization dry time. Specifically, the wall chart (PN 551524-03 Rev A) did not match the sterilization dry time specified in the User Manual Addendum (PN 550986-07_B). This discrepancy could lead to improper sterilization procedures if the wall chart is relied upon exclusively.

Healthcare facilities and users of the da Vinci Si Surgical System should stop using the affected wall charts and contact Intuitive Surgical for instructions on obtaining the corrected documentation. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product: da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Instrument Documentation
Hazard: mis-labeling
sterilization-error
Affected units: 1,034

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

PN 410298-05
-06
-07
-08
-09

Distribution

Distributed nationwide across the United States.

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · mis labeling