- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for breach in sterile barrier of device packaging.
- Affected products (lot / model / serial)
- Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.
- Units affected
- 5,020 (US); 20,770 (OUS)
- Distribution pattern
- US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending.
- Firm location
- Marlborough, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2840-2026
- Recall initiated
- June 30, 2026
- FDA classification date
- July 31, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99300
- Last updated on HTM Vibe
- August 18, 2026