Intuitive Surgical recalls stainless steel reprocessing trays and camera heads for potential sterility breaches. Small holes in sterilization wraps could lead to infection risks during surgery.
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 and 2D camera heads for the IS4000 model. Small holes in the sterilization wrap used with these items could breach sterility and cause infection during surgery.
Small holes in the sterilization wrap used with these trays could allow contamination to enter the surgical site. This breach of sterility might lead to infections during procedures.
Surgical teams using the IS400499-03 model trays and camera heads for minimally invasive procedures are most at risk. Patients undergoing surgery with these devices could face infection risks.
Check for the model number 400499-03 on the stainless steel reprocessing trays and 2D camera heads. These items were sold with the IS4000 system for minimally invasive surgery.
Look for the model number 400499-03 on the stainless steel reprocessing trays and 2D camera heads.
Small holes in the sterilization wrap used with these trays could lead to a potential breach of sterility and risk of infection during surgery.
Check for the model number 400499-03 on the stainless steel reprocessing trays and 2D camera heads.
The recall record does not specify a remedy, so contact Intuitive Surgical directly 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-2329-2020 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-2329-2020 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.
