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: M00513360.
USRadial 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: M00513360.
Recalling Firm: Boston Scientific Corporation
Reason for Recall / Hazard
Potential for breach in sterile barrier of device packaging.
Product Description & Identification
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: M00513360.
Affected Products
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: M00513360.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 99300 |
| Address 1 | 100 Boston Scientific Way |
| Code info | Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094. |
| Postal code | 01752-1234 |
| Report date | 20260812 |
| Product type | Devices |
| Product quantity | 5,020 (US); 20,770 (OUS) |
| Reason for recall | Potential for breach in sterile barrier of device packaging. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260630 |
| Initial firm notification | Letter |
| Center classification date | 20260731 |
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Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.
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🚨 SAFETY ALERT: Boston Scientific Corporation - 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: M00513360. Check if your household is affected: https://therecallfile.com/recalls/radial-jaw-4-jumbo-biopsy-forceps-with-the-following-descriptions-and/FDA-Z-2840-2026
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