RecallReported October 7, 2026
Class II recall by Merit Medical Systems, Inc.
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile St…
FDA's enforcement report of October 7, 2026 lists a Class II recall by Merit Medical Systems, Inc. of South Jordan, UT. Product: Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile St…. Status: Ongoing.
On the record
- Recalling firm
- Merit Medical Systems, Inc.
- Location
- South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3305-2026
- Product type
- Devices
- Recall initiated
- 2026-08-10
- Reported by FDA
- 2026-10-07
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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