Sirtex SIROS D-Vial Prep Set Recall: Particulate Matter Risk
Sirtex recalls SIROS D-Vial Prep Set (product code SIR-10200) due to potential particulate matter in the D-Vial. This single-use medical device may pose a risk if used improperly.
Lower-risk recall
There is a potential presence of particulate matter in the D-Vial.
Contact the company
What happened, in plain English
Sirtex is recalling its SIROS D-Vial Prep Set (product code SIR-10200) because it may contain particulate matter in the D-Vial. This could cause issues if the device is used for medical procedures, though the risk is not described as severe. Read more at govinfonow.com/recall/63250-sirtex-siros-d-vial-prep-set-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63250-sirtex-siros-d-vial-prep-set-recall-particulate-matter-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1275-2021
Cite this page
“Sirtex SIROS D-Vial Prep Set Recall: Particulate Matter Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63250-sirtex-siros-d-vial-prep-set-recall-particulate-matter-risk. Based on FDA recall #Z-1275-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1275-2021%22&limit=1).
Why it’s dangerous
The D-Vial may contain small particles that could enter the bloodstream during medical procedures. This could lead to complications like infections or blockages if the particles are not properly filtered.
Who’s affected
Healthcare professionals who use the SIROS D-Vial Prep Set for medical procedures are most at risk. Patients using this device for single-use medical applications may also be affected.
How to tell if you have this one
Check for the product code SIR-10200 on the SIROS D-Vial Prep Set. Lot numbers 1031234, 1031225, 1031227, and 1031229 are affected.
- Brand
Sirtex- Category
Medical device
What to do — step by step
Check Product Code
Look for the product code SIR-10200 on the SIROS D-Vial Prep Set.
Verify Lot Numbers
Confirm if your device has lot numbers 1031234, 1031225, 1031227, or 1031229.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 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.
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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-1275-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1275-2021 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.