Intuitive Surgical Recalls da Vinci S Camera Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci S Camera Drapes because they may have a cloudy or waxy appearance that could transfer to patients or tear.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk of harm (transfer of substance to patient and tearing) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci S Surgical System IS2000 Camera Drape, 20 Pack (Product number 400027-04). The recall affects 442,475 units of all drape models distributed worldwide.
The recall was initiated because the drapes may exhibit a cloudy or waxy appearance. This defect poses a potential risk of transferring a waxy substance to the patient and a potential for the drape to tear during use.
Healthcare facilities and consumers should stop using the affected drapes and contact Intuitive Surgical for further instructions or a return.
The recalled product
- Product
- da Vinci S Surgical System IS2000, Camera 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 (2)
- Product number 400027-04
- da Vinci (Standard System) Camera Drape
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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