The Recall Desk
HighFDA (Devices)·Z-1385-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Si Camera Head Drapes

Intuitive Surgical is recalling da Vinci Si Camera Head Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to 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 risk-of-harm product (potential transfer of substance to patient and drape failure) where specific injuries or illnesses have not yet been reported, fitting the High severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. The recall affects 442,475 total units across all drape models. The product is identified by product number 420273-02. The recall covers all lot numbers for the cloudy/waxy issue, while no specific lot numbers are identified for the tear issue.

The recall is being conducted because the drapes may exhibit a cloudy or waxy appearance. This condition creates a potential for the waxy substance to transfer to the patient and a potential for the drape to tear. The drapes are designed to cover surgical and non-surgical equipment in clinical settings.

The affected products were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, South America, and the Middle East. Healthcare facilities and consumers who have these specific drapes should stop using them and contact Intuitive Surgical for further instructions.

The recalled product

Product
da Vinci Si Surgical System IS3000, Camera Head 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 420273-02
  • da Vinci Si Camera Head 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 →

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