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Open, Classified

Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.

FDA Recall Z-2838-2026 · 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.

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