Intuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation
Intuitive Surgical is recalling 509 units of 8mm Permanent Cautery Spatulas because deviations in reprocessing steps can cause surface degradation of the housing and accelerate mechanical wear.
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. The hazard involves mechanical wear and surface degradation due to reprocessing deviations, which is a significant defect but does not meet the criteria for Severe (Class I or reported hospitalization/injury) or High (high-risk pathogens or immediate risk of harm without injury reports).
Plain-English summary
Intuitive Surgical, Inc. is recalling 509 units of 8mm Permanent Cautery Spatulas (Part number 470184-04). These devices are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall applies to all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
The recall was initiated because deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. The affected units were distributed in the United States to facilities in Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts.
Healthcare facilities should contact Intuitive Surgical, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 509
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)
- Part number 470184-04
Distribution
Part of a larger recall action
This product is one of 22 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 22 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 · mechanical wear
See all →- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighInfusion pumps recalled because degrading grease may cause excessive therapy delivery
FDA (Devices) · 2025-09-03
- HighX-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion
FDA (Devices) · 2024-05-15
- HighPhilips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk
FDA (Devices) · 2023-04-19
- HighLiko Mobile Patient Lifts Recalled for Missing Bushings and Wear Risk
FDA (Devices) · 2022-02-23