Intuitive Surgical recalls daVinci Harmonic ACE Curved Shears due to potential sterility breaches from damaged packaging during transit. Affected units may have pinholes or small openings in sterile pouches.
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
Intuitive Surgical is recalling all daVinci Harmonic ACE Curved Shears because the sterile packaging might get damaged during shipping, which could cause small holes that break the sterility. This means the surgical tools might not be safe for use without risking infection.
The sterile packaging for these surgical shears could develop pinholes or small openings during shipping. This might allow contaminants to enter the pouch, potentially compromising sterility during surgery. However, the risk is low because the damage is rare and the shears are used in controlled medical settings.
Surgical teams and hospitals that use daVinci Harmonic ACE Curved Shears are affected. The risk is low because the packaging damage is unlikely to happen frequently and only affects sterility during specific surgical procedures.
Check for daVinci Harmonic ACE Curved Shears with any lot number. The recall covers all units produced by Intuitive Surgical.
Inspect the sterile pouch for pinholes or small openings that could compromise sterility.
Yes, the recall covers all lots of daVinci Harmonic ACE Curved Shears.
Look for pinholes or small openings (less than a few millimeters) in the sterile pouch.
The recall 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-0841-2019 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0841-2019 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.
