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.
FDA Recall Z-2840-2026 · Posted 2026-07-31
Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFCL
Date Initiated2026-06-30
Product Quantity5,020 (US); 20,770 (OUS)
Reason for Recall
Potential for breach in sterile barrier of device packaging.
Firm Action
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
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.