Intuitive Surgical Recalls da Vinci S Patient-Cart Monitor Drapes
Intuitive Surgical is recalling da Vinci S Patient-Cart Monitor Drapes due to a cloudy or waxy appearance that may transfer to patients or cause the drape to tear.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential hazards without reporting any actual injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci S Surgical System IS2000 Patient-Cart Monitor Drape, 20 Pack. The product is a medical equipment drape used to cover surgical and non-surgical equipment in clinical settings. The recall involves 442,475 total units across all drape models.
The recall was initiated 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 issue affects all lot numbers for the cloudy/waxy appearance, while no specific lot numbers are associated with the tearing issue.
The affected products were distributed worldwide to numerous countries, including the United States, Canada, and various nations in Europe, Asia, and South America. Healthcare facilities and users of the da Vinci S Surgical System should stop using the affected drapes and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- da Vinci S Surgical System IS2000, Patient-Cart Monitor 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
- 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 number420017-03
- da Vinci (Standard System) Patient-Cart Monitor 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
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Same hazard · material defect
See all →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29