Z-2838-2026 Class II Ongoing
FDA device recall Z-2838-2026 was initiated by Boston Scientific Corporation on June 30, 2026 and is designated Class II. Reason for recall: Potential for breach in sterile barrier of device packaging. The recall status is ongoing. Affected quantity: 5,020 (US); 20,770 (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2026
- Initiation Date
- June 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,020 (US); 20,770 (OUS)
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.
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.
Code Information
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.