- Recalling firm
- Micro Therapeutics, Inc.
- Reason for recall
- Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Affected products (lot / model / serial)
- UDI: 00763000448806/ Lot: D062612, D112860
- Units affected
- 13 units
- Distribution pattern
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2773-2026
- Recall initiated
- June 8, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99326
- Last updated on HTM Vibe
- August 4, 2026