The Recall Desk
HighFDA (Devices)·Z-1393-2015·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 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' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Intuitive Surgical, Inc. is recalling the da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. The recall involves 442,475 total units across all drape models. The product is distributed worldwide, including in the United States and numerous international markets.

The recall is issued because the 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. The cloudy/waxy issue affects all lot numbers, while the tear issue affects specific lot numbers listed in the agency's records.

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, 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 420291-03
  • da Vinci Si Disposable Accessory Kit
  • 4 ARM
  • D142195
  • D142195A
  • D142205
  • D142215
  • D142255
  • D142255A
  • D142265
  • D142265A
  • D142325
  • D142325A
  • D142335
  • D142335A
  • D142345
  • D142395
  • D142405
  • D142405A
  • D142415

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

Same manufacturer · Intuitive Surgical, Inc.

See all →

Same hazard · material transfer

See all →