Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:... recall (Boston Scientific Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Corporation is recalling 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. Reason: Potential for breach in sterile barrier of device packaging.
What is being recalled
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.
Why
Potential for breach in sterile barrier of device packaging.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin)
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2838-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 30, 2026 |
| Reported | August 12, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5,020 (US); 20,770 (OUS) |
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