Embosphere Microspheres Recalled Due to Packaging Sterility Concerns
Merit Medical Systems is recalling Embosphere microspheres because packaging holes may compromise sterility, posing an infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection due to compromised sterility) where no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Merit Medical Systems, Inc. is recalling specific lots of Embosphere microspheres used for embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels. The recall involves 104 units of Embosphere 500-700, 700-900, and 900-1200 micrometer 2 mL Syringe Sterile Steam products.
The recall was initiated because the packaging for these devices may have holes that affect the sterile barrier. If the devices are used in this condition, there is a risk of infection. The affected products were distributed nationwide in the United States (specifically in California and Georgia) and internationally in France, Ireland, Canada, and Switzerland.
Healthcare providers and facilities should stop using the affected lots immediately. The source text does not provide specific instructions for disposal or return, but users should contact Merit Medical Systems for further guidance on handling the recalled devices.
The recalled product
- Product
- Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF: S820GH/CAB; Embosphere 900-1200 micrometer 2 mL Syringe Sterile Steam, REF: S1020GH/C, S1020GH/EUA
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- S420GH/EUA/00884450116715/X3467294-1
- S620GH/EUA/00884450109519/X3472987-1
- S820GH/CAB/00884450364154/X3472923-A
- S1020GH/C/00884450403136/X3482321-5
- S1020GH/EUA/00884450109519/X3482321-1
Distribution
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