Boston Scientific Corporation recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:

Recalling company

Boston Scientific Corporation

Product

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.

Reason

Potential for breach in sterile barrier of device packaging.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jun 30, 2026

Reported

Aug 12, 2026

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.

Status

Ongoing

Quantity

5,020 (US); 20,770 (OUS)

Lot / codes

1. Outer Box UPN: M00513401. Inner Box UPN: M00513400. GTIN: 08714729777960. Lot Number: 38508541. 2. Outer Box UPN: M00513402. Inner Box UPN: M00513400. GTIN: 08714729778028. Lot Numbers: 38517807. 3. Outer Box UPN: M00513411. Inner Box UPN: M00513410. GTIN: 08714729777984. Lot Number: 38488064.

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2838-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2838-2026 in the FDA Enforcement Report. Also see FDA recall press releases.