The Recall Desk
HighFDA (Devices)·Z-1392-2015·Announced 2015-04-15

Intuitive Surgical Recalls da Vinci Si Disposable Accessory Kits

Intuitive Surgical is recalling da Vinci Si Surgical System 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 is classified as FDA Class II, and the hazard involves a risk of harm (transfer of substance to patient and drape tearing) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. The recall involves 442,475 total units for all drape models, which were distributed worldwide to numerous countries including the United States, Canada, and various nations in Europe, Asia, and the Americas.

The recall was initiated because the Microtek Medical Equipment Drapes may exhibit a cloudy or waxy appearance. This defect presents a potential for the waxy substance to transfer to the patient and a potential for the drape to tear during use. The issue affects all lot numbers for the cloudy/waxy appearance, while specific lot numbers are identified for the tearing issue.

Healthcare facilities and consumers should stop using the affected disposable accessory kits. Intuitive Surgical is the recalling firm responsible for managing the recall process.

The recalled product

Product
da Vinci Si Surgical System IS3000, 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 420290-03
  • da Vinci Si Disposable Accessory Kit
  • 3 ARM
  • D142175A
  • D142185
  • D142185A
  • D142235
  • D142235A
  • D142245
  • D142245A
  • D142255
  • D142305
  • D142305A
  • D142315
  • D142315A
  • D142345
  • D142375
  • D142375A
  • D142385
  • D142385A

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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