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CLASS II · ModerateFDA

Merit Medical Systems, Inc. recalls Scout MD

📅 Aug 27, 2026 · 📍 AZ, CA, FL, IN, LA, NV, RI
Recalling company
Merit Medical Systems, Inc.
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
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 27, 2026
Reported
Oct 21, 2026
Distribution
US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Status
Ongoing
Lot / codes
MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
Company location
South Jordan, UT
Recall type
Voluntary: Firm initiated
Recall number
Z-0187-2027
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0187-2027 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.