Boston Scientific Radial Jaw 4 forceps recalled for packaging risk
Boston Scientific is recalling certain Radial Jaw 4 Standard Capacity biopsy forceps because of a potential breach in the sterile barrier of the device packaging. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- Check your inventory for the outer box UPNs M00513401, M00513402, or M00513411, with the matching inner box UPNs and lot numbers listed in the notice.
- Set aside affected lots and do not use them on patients.
- The notice does not state a remedy. Contact Boston Scientific Corporation for instructions on return or replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 5,020 (US); 20,770 (OUS)
- Illnesses reported
- None reported
- Manufactured in
- 100 Boston Scientific Way, Marlborough, MA, United States
- Classification
- Class II
- Recall number
- Z-2838-2026
In the FDA's words
- 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. Potential for breach in sterile barrier of device packaging. 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. 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. Affected quantity: 5,020 (US); 20,770 (OUS)
- Hazard
- Potential for breach in sterile barrier of device packaging.
3 products in this recall
Boston Scientific Radial Jaw 4 forceps recalled for packaging risk
Boston Scientific is recalling three Radial Jaw 4 biopsy forceps products (Standard Capacity, Large Capacity and Jumbo) for a potential breach in the sterile barrier of the device packaging. The notice reports no injuries, and the products were distributed across the US and internationally, with international distribution still pending.
The agency lists each product separately. Check every one you might have.
- 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… (this page)Z-2838-2026 · 5,020 (US); 20,770 (OUS)
- 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…Z-2839-2026 · 5,020 (US); 20,770 (OUS)
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M0…Z-2840-2026 · 5,020 (US); 20,770 (OUS)
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