Class 2 Device Recall Scout MD

• Date Initiated by Firm: August 27, 2026
• Date Posted: October 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0187-2027
• Recall Event ID: 99901
• 510(K)Number: K252892
• Product Classification: Marker, radiographic, implantable - Product Code NEU
• 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
• Code Information: MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
• FEI Number: 1721504
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Merit Customer Service; 800-356-3748
• Manufacturer Reason for Recall: The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
• FDA Determined 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 notice is immediately shared with them and note the quantity distributed on the CRF. 5. Please fill out, scan and email the completed CRF to Customer Service at RESPONSE@merit.com within 7 business days. All affected products shipped to you must be accounted for on the CRF. 6. Immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.
• Distribution: US: AZ, CA, FL, IN, LA, NV, RI OUS: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NEU