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Moderate riskFDA DeviceClass II

Boston Scientific Radial Jaw 4 forceps recalled for packaging risk

Boston Scientific has recalled certain Radial Jaw 4 Large Capacity Biopsy Forceps because the packaging may not keep the devices sterile. The notice reports no injuries. About 5,020 units were distributed in the US, and about 20,770 went to other countries.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. Set aside affected units from the listed lots and do not use them on patients.
  2. Match the outer and inner box UPNs and lot numbers in the notice to your inventory, for example outer box UPN M00513321, lot 38494988.
  3. The notice does not specify a remedy; contact Boston Scientific for return or replacement instructions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (0 months and older)

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-2839-2026

In the FDA's words

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. Potential for breach in sterile barrier of device packaging. 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. 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.

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