Boston Scientific Corporation: Forceps, Biopsy, Non-electric

Recall Summary Boston Scientific is recalling Radial Jaw 4 Jumbo 240cm biopsy forceps (specific box UPNs: M00513363 and M00513360) because the sterile packaging may have been compromised. This Class I recall affects units distributed nationwide across the U.S. and internationally. The forceps are medical devices used to obtain tissue samples during procedures.

Recalling firm
Boston Scientific Corporation
Product
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.
Reason
Potential for breach in sterile barrier of device packaging.
Classification
Class I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-30
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/25ff99a1-9159-472d-a725-8d6b5f4d0f05