- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.
- Affected products (lot / model / serial)
- MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911
- Distribution pattern
- US: AZ, CA, FL, IN, LA, NV, RI OUS: None
- Firm location
- South Jordan, UT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0187-2027
- Recall initiated
- August 27, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99901
- Last updated on HTM Vibe
- October 27, 2026
