Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk
Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small 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 (infection risk) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 16 units of the Stainless Steel Reprocessing Tray, 2D Camera Head, IS4000, Model No. 400499-03. The recall involves all batch numbers and is distributed worldwide, including nationwide in the United States and in Canada.
The recall is issued because small but detectable holes in the sterilization wrap used with the trays could lead to a potential breach of sterility. Certain features on the trays may cause these holes during handling and storage, creating a risk of infection for patients.
Healthcare facilities and users of these trays should stop using the affected products and contact Intuitive Surgical for further instructions on the recall.
The recalled product
- Product
- STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 16
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. 400499-03
- All Batch Numbers
- UDI: 00886874115855
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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