Boston Scientific Corporation: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Boston Scientific Corporation
- Product
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
- Reason / hazard
- Potential for breach in sterile barrier of device packaging.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-06-30
- Code info
- Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.
- Product quantity
- 5,020 (US); 20,770 (OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Marlborough
- State
- MA
- Country
- United States
- Event id
- 99300
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