Intuitive Surgical Recalls da Vinci SP Instrument Arm Drapes
Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.
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 risk-of-harm product (sterile barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,818 pouches of da Vinci SP Instrument Arm Drape (REF 430013-12). The recall was initiated because the instrument drape may tear while draping the Patient Side Cart, which presents a breach in the sterile barrier.
The affected product is distributed in the United States and South Korea. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Healthcare facilities should stop using the affected drapes and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Drapes
- Hazard
- Affected units
- 1,818
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 (1)
- Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
Distribution
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Similar recalls
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