FDAFDA recall Z-0187-2027 · Oct 21, 2026
Merit Medical Systems, Inc.: Scout MD recall
Recall found
Product
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
Reason for recall
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-27
Source: openFDA enforcement record Z-0187-2027 · search recall number Z-0187-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.