Intuitive Surgical recalls 5-packs of 19G Ion Flexison Biopsy Needles with potential sheath tip separation. Affected lots include S90200303 to S90210414. Contact for remedy.
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Intuitive Surgical is recalling 5-packs of 19G Ion Flexison Biopsy Needles where the sheath tip might separate from the shaft. This could cause injury during medical procedures if the needle slips.
The sheath tip on the biopsy needle could detach from the shaft during use. This separation might cause the needle to slip, potentially leading to injury if the needle moves unexpectedly during a medical procedure.
Healthcare professionals using these needles for biopsies are most at risk. Patients receiving procedures with the recalled needles may also be affected.
Check for the model number 490104-09 or 49004-10 on the packaging. The affected lots are listed as S90200303 through S90210414 in the recall notice.
Look for the lot number on the packaging, which should be one of the listed affected numbers: S90200303 to S90210414.
No, this recall is for medical use only as the product is prescription-only and used in clinical settings.
Check the lot number on the packaging; affected lots are S90200303 through S90210414 as listed in the recall notice.
The recall notice does not specify a remedy, so contact Intuitive Surgical directly for further instructions.
We’ve drafted a message you can send Intuitive Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0106-2022 — Intuitive Surgical Intuitive Surgical Hello, I own a Intuitive Surgical that is covered by recall Z-0106-2022 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.
