The Recall Desk
HighFDA (Devices)·Z-1386-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Si Monitor Drapes Due to Waxy Appearance

Intuitive Surgical is recalling da Vinci Si Monitor Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.

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: The recall involves a medical device with a risk of harm (transfer of waxy substance to patients and potential tearing) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000 Monitor Drape, 20 Pack (Product number 420281-02). The recall involves 442,475 total units across all drape models. These drapes are used to cover various surgical and non-surgical equipment in clinical settings.

The recall was initiated because the drapes may exhibit a cloudy or waxy appearance. This defect presents a potential for the waxy substance to transfer to the patient and a potential for the drape to tear. The issue affects all lot numbers for the cloudy/waxy appearance, while no specific lot numbers are associated with the tearing issue.

The affected products were distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Americas. Consumers and healthcare facilities should stop using these drapes and contact Intuitive Surgical for further instructions.

The recalled product

Product
da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Drapes
Hazard
Affected units
442,475

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 (2)

  • Product number 420281-02
  • da Vinci Si Monitor Drape

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · material transfer

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