Intuitive Surgical Recalls da Vinci S Camera Arm Drapes
Intuitive Surgical is recalling da Vinci S Camera Arm Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
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 risk-of-harm product (potential 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.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci S Surgical System IS2000 Camera Arm Drape, 20 Pack (Product number 400016-04). 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 condition creates a potential for the waxy substance to transfer to the patient and a potential for the drape to tear. The issue affects all lot numbers for the cloudy/waxy appearance, while no specific lot numbers are associated with the tear issue.
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 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 400016-04
- da Vinci (Standard System) Camera 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.
See all 14 products in this recall →Related recalls
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