FDA Device recall Z-2404-2026
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 by Boston Scientific Neuromodulation, citing sterile anchors my lack sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2404-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-29 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | US |
Product
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Reason
Sterile anchors my lack sterility assurance.
Identifiers
| code_info | GTIN: 08714729905318/Lot # 35107836 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2026%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.