Intuitive Surgical Ion Flexison Biopsy Needle 19G Recall: Sheath Tip May Separate
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.
Use caution until it’s fixed
Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62029-intuitive-surgical-ion-flexison-biopsy-needle-19g-recall-sheath-tip.
Source Summary by GovInfoNow · govinfonow.com/recall/62029-intuitive-surgical-ion-flexison-biopsy-needle-19g-recall-sheath-tip · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0106-2022
Cite this page
“Intuitive Surgical Ion Flexison Biopsy Needle 19G Recall: Sheath Tip May Separate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62029-intuitive-surgical-ion-flexison-biopsy-needle-19g-recall-sheath-tip. Based on FDA recall #Z-0106-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0106-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Healthcare professionals using these needles for biopsies are most at risk. Patients receiving procedures with the recalled needles may also be affected.
How to tell if you have this one
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.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot number on the packaging, which should be one of the listed affected numbers: S90200303 to S90210414.
Where it went and when
Where it was distributed
Distributed in 25 states and D.C., and outside the U.S.
FDA distribution: “US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Arkansas, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall for home use?
No, this recall is for medical use only as the product is prescription-only and used in clinical settings.
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Where this comes from
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.
- Official source: FDA Recall #Z-0106-2022 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0106-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.