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Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Out

FDA device recall Z-2839-2026 · posted 2026-07-31 · Open, Classified

Recall details

Recalling firm
Boston Scientific Corporation
Reason for recall
Potential for breach in sterile barrier of device packaging.
Action taken
Firm began notifying consignees via FedEx Priority Overnight on June 30, 2026. Customers were instructed to check their inventory, remove affected product, and return it to Boston Scientific. Customers should immediately stop further use or distribution of the product.
Root cause
Process control
Status
Open, Classified
Product code
FCL
Quantity affected
5,020 (US); 20,770 (OUS)
Distribution
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 Internation
Date initiated
2026-06-30
Date posted
2026-07-31
Location
Marlborough, MA

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