Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk
Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.
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 (potential infection due to sterility breach) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,757 units of the Stainless Steel Reprocessing Tray, 8mm Endoscope, IS4000, Model No. 400498-02. These trays are designed to enable complex surgery using a minimally invasive approach. The recall covers all batch numbers and is distributed worldwide, including nationwide in the United States and in Canada.
The recall was initiated because small but detectable holes in the sterilization wrap used with the 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility. Certain features on the trays may cause these holes during handling and storage, which presents a risk of infection.
Healthcare facilities and consumers who have these specific trays should stop using them immediately. Intuitive Surgical is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,757
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 (3)
- Model No. 400498-02
- All Batch Numbers
- UDI: 00886874115848
Distribution
Part of a larger recall action
This product is one of 2 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 2 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 · infection
See all →- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
Similar recalls
- SevereCustomed Incision and Drainage Trays Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- ModerateIntuitive Surgical Recalls 8mm Small Grasping Retractor for Reprocessing Deviations
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues
FDA (Devices) · 2014-12-03
- HighIntuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations
FDA (Devices) · 2014-12-03
- ModerateIntuitive Surgical Recalls 8mm Permanent Cautery Spatulas for Housing Degradation
FDA (Devices) · 2014-12-03
- HighSterile endoscopy trays recalled for potential blade packaging puncture
FDA (Devices) · 2023-02-15