Class IIOngoing
Merit Medical Systems, Inc. recalls Scout MD
Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- Merit Medical Systems, Inc.
- Reason
- The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
- Hazard
- FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
- Who’s affected
- US: AZ, CA, FL, IN, LA, NV, RI OUS: None
- Where
- Arizona, California, Florida, Indiana, Louisiana, Nevada, Rhode Island
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99901…
Products
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Codes/lots: MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911Recall no. Z-0187-2027Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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