# Class II recall Z-0187-2027: Merit Medical Systems, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0187-2027 |
| Recalling firm | Merit Medical Systems, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Distribution | US: AZ, CA, FL, IN, LA,  NV, RI OUS: None |
| Recall initiated | 2026-08-27 |
| Reported | 2026-10-21 |
| Firm location | South Jordan, UT, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.