Recall Z-0187-2027 ยท NEU Marker, Radiographic, Implantable
Merit Medical Systems, Inc.
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
| Date | Oct 15, 2026 (initiated Aug 27, 2026) |
| Status | Open, Classified |
| Reason | The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. |
| Root cause | Process control |
| Action | On August 27, 2026, Merit Medical issued a Urgent Medical Device Recall Notice to affected consignees via FedEx. Merit ask consignees to take the following actions: 1. Immediately determine if any of the devices identified in the attached Customer ResponseForm (CRF) are within your facility. 2. Immediately discontinue the use of the affected lots of the SCOUT MD Delivery System. 3. Ensure that applicable personnel within your organization are made aware of this recall. 4. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notic |
| Distribution | US: AZ, CA, FL, IN, LA, NV, RI OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252892 | SCOUT MD Surgical Guidance System Merit Medical Systems, Inc., Dec 19, 2025 |