Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk
Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.
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 is classified as FDA Class II and involves a risk-of-harm product (foreign material introduction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling the EndoWrist Suction Irrigator, a single-use instrument used as an accessory to the EndoWrist Surgical System for endoscopic surgery. The recall involves 3,108 units (518 boxes of 6 units) with Part Number 480299-04 and UDI 00886874114810. The affected lots include T10180226 and onward.
The firm identified a potential for silicone particles to be generated within the device. If generated, these particles may be introduced into the patient with irrigation. The recall is classified as Class II by the FDA.
The product was distributed worldwide, including the United States, Australia, Italy, Switzerland, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
- Manufacturer
- Intuitive Surgical, Inc.
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)
- Lots: T10180226 and onward
- Part Numbers: 480299-04 (UDI 00886874114810)
Distribution
Distributed nationwide across the United States.
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 · foreign material
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- ModerateSo Delicious Dairy Free Salted Caramel Cluster Cashewmilk Recalled for Foreign Material
FDA (Food) · 2026-09-30
- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Similar recalls
- HighIntuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments
FDA (Devices) · 2017-04-19
- ModerateIntuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns
FDA (Devices) · 2015-03-11
- ModerateIntuitive Surgical Recalls EndoWrist Vessel Sealers Due to Grip Interference
FDA (Devices) · 2015-03-04
- SevereIntuitive Surgical Recalls EndoWrist Stapler 45 Instruments
FDA (Devices) · 2014-10-22
- HighIntuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk
FDA (Devices) · 2018-09-19
- HighIntuitive Surgical Recalls da Vinci Xi Stapler Instruments Due to Motion Risk
FDA (Devices) · 2016-05-04