The Recall Desk
HighFDA (Devices)·Z-1390-2015·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 risk of tearing.

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 defect that poses a risk of harm (transfer of substance to patient and tearing) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. The recall involves 442,475 total units across all drape models. These products are used to cover surgical and non-surgical equipment in clinical settings.

The recall is being issued because the drapes may exhibit a cloudy or waxy appearance. This defect creates a potential for the waxy substance to transfer to the patient. Additionally, the drapes have a potential to tear.

The affected products were distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and South America. The recall covers all lot numbers for the cloudy/waxy issue and specific lot numbers for the tear issue. Users should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 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 420258-01
  • da Vinci S Disposable Accessory Kit
  • 4 ARM
  • D142205
  • D142275
  • D142345
  • D142485
  • D142625
  • D142685
  • D142765
  • D142835
  • D142905
  • D142965
  • D143035
  • D143105
  • D143175
  • D143245
  • D143315
  • D143385
  • D143445

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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