FDA Device recall Z-3305-2026
Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA by Merit Medical Systems, citing microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3305-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | S420GH/EUA/00884450116715/X3467294-1, S620GH/EUA/00884450109519/X3472987-1, S820GH/CAB/00884450364154/X3472923-A, S1020…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Merit Medical Systems
- Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI co…
FDA Device · Class II · 2026-06-24 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
FDA Device · Class II · 2026-05-06 · Merit Medical Systems - DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028…
FDA Device · Class I · 2026-04-01 · Merit Medical Systems
All Merit Medical Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3305-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.