The Recall Desk
ModerateFDA (Devices)·Z-1388-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Camera Arm Drapes for Defects

Intuitive Surgical is recalling da Vinci S/Si Camera 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 hazards involve potential transfer of a waxy substance and tearing, which are quality defects without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk contamination or precautionary recalls.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci S / Si Surgical System IS2000 / IS3000 Camera Arm Drape, 20 Pack. The product is used to cover surgical and non-surgical equipment in clinical settings. The recall involves 442,475 total units across all drape models.

The recall was initiated because the drapes may exhibit 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 cloudy/waxy issue affects all lot numbers, while the tear issue affects specific lot numbers listed in the agency records.

The affected products were distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and the Americas. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.

The recalled product

Product
da Vinci S / Si Surgical System IS2000 / IS3000, Camera 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 420022-02
  • da Vinci S Camera Arm Drape
  • D142205A
  • D142275
  • D142275A
  • D142315
  • D142325
  • D142335
  • D142345
  • D142345A
  • D142375
  • D142375A
  • D142385
  • D142485
  • D142625
  • D142625A
  • D142655
  • D142685
  • D142695
  • D142695A

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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