Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations
Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.
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 high-risk medical device where mechanical wear and surface degradation pose a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8mm ProGrasp Forceps intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The recall involves all 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings, identified by part number 470093-04.
The recall is due to deviations in reprocessing steps from those stated in the reprocessing instructions. These deviations can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
The affected products were distributed in the United States to Florida, Texas, New York, Nevada, Oregon, Indiana, Utah, and Massachusetts. No specific number of affected units is stated in the source text.
The recalled product
- Product
- 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- 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 (1)
- Part number: 470093-04
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
Similar recalls
- HighPrograsp Surgical Forceps Recalled Due to Frayed Grip Cables
FDA (Devices) · 2025-01-22
- HighProGrasp Forceps Recalled Due to Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Recalls 8mm Precise Bipolar Forceps Due to Cautery Plug Defect
FDA (Devices) · 2013-06-05
- HighIntuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage
FDA (Devices) · 2015-06-24
- HighSurgical Forceps Recalled for Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects
FDA (Devices) · 2025-01-22