Scout MD recall (Merit Medical Systems, Inc.)
Medical deviceClass IIOngoing
Summary: Merit Medical Systems, Inc. is recalling 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.
What is being recalled
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
Why
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: AZ, CA, FL, IN, LA, NV, RI OUS: None (states named: Arizona, California, Florida, Indiana, Louisiana, Nevada, Rhode Island)
How to tell if yours is affected
MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0187-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 27, 2026 |
| Reported | October 21, 2026 |
| Company | Merit Medical Systems, Inc. |
| Company location | South Jordan, UT, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Merit Medical Systems, Inc. · all medical device recalls · recalls from August 2026