Intuitive Surgical recalls stainless steel reprocessing trays for 8mm endoscopes due to potential sterility breaches from small holes in sterilization wraps. Affected units include Model 400498-02 with all batch numbers.
Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays and handheld camera sterilization trays could lead to a potential breach of sterility and risk of infection. Certain features on the trays with handling and storage may cause these holes.
Intuitive Surgical is recalling stainless steel reprocessing trays for 8mm endoscopes because small holes in the sterilization wrap could cause infections. This affects medical devices used in minimally invasive surgery.
The sterilization wrap for the trays can develop small holes during handling or storage. These holes might allow contamination, breaking the sterile seal and increasing infection risk during surgery.
Healthcare professionals using the recalled trays for endoscopic procedures are most at risk. Patients undergoing surgery with these devices could face infection risks if the sterility breach occurs.
Check for the model number 400498-02 on the tray. All batch numbers are affected. The product is used in minimally invasive surgery procedures.
Look for the model number 400498-02 and all batch numbers on the stainless steel reprocessing tray.
Small holes in the sterilization wrap could breach sterility and risk infection during surgery.
The product is the stainless steel reprocessing tray for 8mm endoscopes with model number 400498-02 and all batch numbers.
The recall record does not specify a remedy, so contact Intuitive Surgical for guidance.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2328-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2328-2020 from Intuitive Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
