Merit Medical Systems, Inc.: Marker, Radiographic, Implantable
Recall Summary Merit Medical Systems is recalling Scout MD Delivery System markers used with their surgical guidance system because the implantable clip may not deploy properly, which could prevent the device from working as intended during surgery. The recall affects units distributed in Arizona, California, Florida, Indiana, Louisiana, Nevada, and Rhode Island. This is a Class II recall affecting medical devices.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-27
- Status
- Open, Classified
- Areas affected
- AZ, CA, FL, IN, LA, NV, RI
- Distribution
- US: AZ, CA, FL, IN, LA, NV, RI OUS: None
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d39d94b0-5759-40af-b9a5-d6e94ee97140