Use caution Medical device recall · FDA · Published August 10, 2026

Embosphere 500-700 Micrometer Syringe Recall: Packaging Holes Risk Infection

Merit Medical Systems recalls 104 units of Embosphere 500-700 micrometer syringes with packaging holes that could lead to infection if used. Stop using immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3305-2026Medical device Merit Medical Systems ›

Use caution until it’s fixed

Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.

✎ GovInfoNow plain-language explainer

Merit Medical Systems is recalling 104 units of Embosphere 500-700 micrometer syringes because packaging holes may compromise the sterile barrier, risking infection if used. This recall affects patients receiving medical treatments involving these syringes. Read more at govinfonow.com/recall/1449397-merit-medical-systems-inc-recalls-embosphere-500-700-micrometer-2.

Source Summary by GovInfoNow · govinfonow.com/recall/1449397-merit-medical-systems-inc-recalls-embosphere-500-700-micrometer-2 · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3305-2026

Cite this page

“Embosphere 500-700 Micrometer Syringe Recall: Packaging Holes Risk Infection.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449397-merit-medical-systems-inc-recalls-embosphere-500-700-micrometer-2. Based on FDA recall #Z-3305-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3305-2026%22&limit=1).

The FDA announced on August 10, 2026, that Merit Medical Systems, Inc. is recalling Embosphere syringes due to packaging holes that may compromise the sterile barrier and lead to infection. The agency issued recall number Z-3305-2026 for the voluntary Class II action.

How to tell if you have it

Brand: Merit Medical Systems
Product: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA
Product: Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB
Product: Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA
Lot codes: X3467294-1, X3472987-1, X3472923-A, X3482321-5, X3482321-1
UPCs: 00884450116715, 00884450109519, 00884450364154, 00884450403136
Distribution: US Nationwide (CA, GA), France, Ireland, Canada, Switzerland

The hazard

The microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier. If used, this defect could lead to infection.

Context

GovInfoNow's records show Merit Medical Systems, Inc. has 37 other recalls on record since February 24, 2006. Other recent recalls of similar products include the Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026) and the Merit Medical ProGuide Dialysis Catheters Recall (February 13, 2026). Medline Convenience Kits faced recalls on June 12, 2026, for risks including sterile packaging breach and microbial contamination from packaging wrinkles.

How to tell if you have this one

Check for the product name 'Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam' with reference codes S420GH/EUA, S620GH/EUA, S820GH/CAB, or S1020GH/C, S1020GH/EUA. These were distributed worldwide, including the US states of California, Georgia, and other countries.

Brand
Merit Medical Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop using immediately
Discard the syringe if you have it and it has the reference codes listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, GA and the countries of France, Ireland, Canada, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Georgia.

Recall timeline

FDA published this recall 58 days after the firm started it.

Aug 10, 2026Firm started the recall
Sep 25, 2026FDA classified it Class II
Oct 7, 2026Published in FDA’s Enforcement Report
Oct 13, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Where were these syringes sold?

Worldwide, including US states of California and Georgia, and countries like France, Ireland, Canada, and Switzerland.

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Link to this recall

<a href="https://govinfonow.com/recall/1449397-merit-medical-systems-inc-recalls-embosphere-500-700-micrometer-2">Embosphere 500-700 Micrometer Syringe Recall: Packaging Holes Risk Infection (GovInfoNow)</a>

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-3305-2026 (August 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3305-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 14, 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.