- Recalling firm
- Solstice Corporation
- Reason for recall
- The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
- Affected products (lot / model / serial)
- part #: M15RM; UDI-DI: 00854623006068; UPC-A; lot #: M15RM26A;
- Units affected
- 736
- Distribution pattern
- Worldwide - US Nationwide distribution in the states and territory of CA, FL, IL, IN, MN, MO, NY, OH, PA, TX, WV and Puerto Rico. The country of Canada.
- Firm location
- South Portland, ME, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0268-2027
- Recall initiated
- September 22, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99956
- Last updated on HTM Vibe
- November 3, 2026
