Recall Z-0187-2027— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2026-08-27. It names one FDA 510(k) clearance: K252892. 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..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-27
- Firm location
- South Jordan, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.