Device recall
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
- Recall number
- Z-0187-2027
- Event id
- 99901
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Aug 27, 2026
- Center classification date
- Oct 15, 2026
- Product code
- NEU
- Device type
- Marker, Radiographic, Implantable
- Reason
- The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
- Root cause
- Process control
- Code info
- MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
- Distribution
- US: AZ, CA, FL, IN, LA, NV, RI OUS: None
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K252892
- Location
- South Jordan, UT, United States