The Recall Desk
HighFDA (Devices)·Z-1389-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci S Disposable Accessory Kits

Intuitive Surgical is recalling da Vinci S Disposable Accessory Kits due to a cloudy or waxy appearance that may transfer to patients and a potential for 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 tearing) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. The product is a disposable accessory kit used to cover surgical and non-surgical equipment in clinical settings. The recall affects 442,475 total units across all drape models.

The recall was initiated because the product exhibits a cloudy or waxy appearance. This defect creates a potential for the waxy substance to transfer to the patient and a potential for the drape to tear. The cloudy or waxy issue affects all lot numbers, while the tear issue is associated with specific lot numbers listed in the agency's structured data.

The affected products were distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and South America. Users of these products should stop using the affected kits and contact Intuitive Surgical for further instructions.

The recalled product

Product
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 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 420256-01
  • da Vinci S Disposable Accessory Kit
  • 3 ARM
  • D142275
  • D142345
  • D142375
  • D142625
  • D142695
  • D142765
  • D142835
  • D142905
  • D142975
  • D143035
  • D143115
  • D143175
  • D143255
  • D143315
  • D143385
  • D143445
  • D150085

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

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