Recall Z-2838-2026— Boston Scientific Corporation

Name: FDA recall Z-2838-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-06-30. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-06-30
Firm location: Marlborough, MA, United States

Product description

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 for recall

Potential for breach in sterile barrier of device packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.