Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns
Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.
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 hazard is a potential sterility breach due to packaging damage. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Intuitive Surgical, Inc. is recalling 706 units of the Vacuum Source Tubing Set for the EndoWrist Stabilizer, part number 420187-05. This product is used with the da Vinci S (IS2000) and Si (IS3000) Surgical Systems to stabilize the heart during coronary artery surgery.
The recall was initiated because the outer pouch of the tubing set may have been compromised during shipping. This damage can result in small pinholes that compromise the sterility of the pouch's outer surface.
The affected units were distributed in the US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, and the United Kingdom. Users should stop using the product and contact Intuitive Surgical for instructions on return or replacement.
The recalled product
- Product
- Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical En
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 706
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)
- all PN 410187-05
Distribution
Distribution scope not specified by the agency.
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