The Recall Desk
ModerateFDA (Devices)·Z-1387-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Instrument Arm Drapes Due to Defects

Intuitive Surgical is recalling da Vinci S/Si Instrument Arm Drapes due to a cloudy/waxy appearance that may transfer to patients and a risk of tearing.

What this means for you

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 source text does not report any illnesses, injuries, or hospitalizations, and the hazards (waxy transfer and tearing) are described as potential risks without confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci S / Si Surgical System IS2000 / IS3000 Instrument Arm Drape, 20 Pack (Product number 420015-03). The recall involves 442,475 total units across all drape models. The product is distributed worldwide, including in the United States, Canada, and numerous countries in Europe, Asia, South America, and the Middle East.

The recall is being conducted because the drapes have a cloudy or waxy appearance with the potential to transfer a waxy substance to the patient. Additionally, there is a potential for the drape to tear. The source text identifies specific lot numbers associated with the tear issue, while the cloudy/waxy issue affects all lot numbers.

This recall is classified as Class II by the U.S. Food and Drug Administration. No illnesses or injuries are reported in the source text. Healthcare facilities and consumers should stop using the affected drapes and contact Intuitive Surgical for instructions on how to return or dispose of the product.

The recalled product

Product
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm 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 (20)

  • Product number 420015-03
  • da Vinci S / Si Instrument Arm Drape
  • D142535
  • D142895
  • D143255
  • D150135A
  • D150555
  • DA142695A
  • DA143465A
  • D142175A
  • D142535A
  • D142895A
  • D143255A
  • D150145
  • D150555A
  • DA142725
  • DA143515
  • D142185
  • D142545
  • D142905

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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