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Z-2839-2026Class II

Boston Scientific Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Boston Scientific Corporation
Product type
Device
Status
Ongoing
Report date
2026-08-12
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 International distribution pending.
Firm state
MA
Product quantity
5,020 (US); 20,770 (OUS)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Potential for breach in sterile barrier of device packaging.

Product description

Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.

Code / lot info

1. Outer Box UPN: M00513321; Inner Box UPN: M00513320. GTIN: 08714729648796. Lot Numbers: 38494988. 2. Outer Box UPN: M00513322; Inner Box UPN: M00513320. GTIN: 08714729648802. Lot Numbers: 38497139. 3. Outer Box UPN: M00513331; Inner Box UPN: M00513330. GTIN: 08714729648819. Lot Numbers: 38509777. 4. Outer Box UPN: M00513332; Inner Box UPN: M00513330. GTIN: 08714729648826. Lot Numbers: 38499451. 5. Outer Box UPN: M00513333; Inner Box UPN: M00513330. GTIN: 08714729755494. Lot Number: 38519443.

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →