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.
What this means for you
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.
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