Boston Scientific Corporation: Forceps, Biopsy, Non-electric
Boston Scientific is recalling certain Radial Jaw 4 biopsy forceps used in medical procedures because the sterile packaging may have been compromised, potentially allowing contamination. The affected products are specific models of 240cm forceps sold in boxes of 20 or 40 units, distributed nationwide across the US and internationally. This is a Class I recall, the most serious classification.
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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/424a7f7b-2895-421f-97b0-b205a10827df