Intuitive Surgical Recalls da Vinci S Arm Drapes Due to Waxy Appearance
Intuitive Surgical is recalling da Vinci S Surgical System arm drapes due to a cloudy, waxy appearance that may transfer to patients or cause 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. The hazard involves a risk of harm (transfer of substance to patient and drape tearing) in a medical device, 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 Arm Drape, 20 Pack (Product number 400015-03). The recall affects 442,475 total units across all drape models. The product is distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
The recall was initiated because the drapes exhibit a cloudy or waxy appearance. This defect creates a potential for the waxy substance to transfer to the patient during use. Additionally, there is a potential for the drape to tear. The source text does not specify lot numbers for the waxy issue, noting 'ALL lot numbers,' and states 'None' for the tear issue.
Healthcare facilities and users of the da Vinci S Surgical System should stop using the affected arm drapes. Intuitive Surgical is the recalling firm responsible for managing this Class II recall. The source text does not provide specific instructions for disposal or replacement, but users should contact the manufacturer for further guidance.
The recalled product
- Product
- da Vinci S Surgical System IS2000, Arm 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 400015-03
- da Vinci (Standard System) Inst. Arm 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.
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