Radial Jaw 4 Jumbo Biopsy Forceps with the following recall: Sterility Concern
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…
Why was Radial Jaw 4 Jumbo Biopsy Forceps with the following recalled?
Potential for breach in sterile barrier of device packaging.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.
- 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…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 5,020 (US); 20,770 (OUS)
- 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.
- Recall date
- August 12, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)