Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with reported hospitalization or significant injury are scored as Severe (4). While no injuries are reported, the sterile barrier breach poses a direct risk of infection in medical procedures, warranting a Severe classification.
Plain-English summary
Boston Scientific Corporation is recalling Radial Jaw 4 Jumbo Biopsy Forceps, specifically the 240cm model, due to a potential breach in the sterile barrier of the device packaging. The product is identified by Outer Box UPN M00513363, Inner Box UPN M00513360, GTIN 08714729761914, and Lot Number 38496094.
The recall affects 5,020 units distributed in the United States and 20,770 units distributed outside the United States. Distribution in the US is nationwide, including 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, with international distribution pending.
Healthcare facilities and customers who received the affected products should stop using them immediately and contact Boston Scientific for instructions on returning the devices. No illnesses or injuries have been reported in connection with this recall.
This is a Class II recall issued by the U.S. Food and Drug Administration, meaning the product could cause temporary or medically reversible adverse health consequences, or where the probability of serious temporary adverse health consequences is remote.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Biopsy Forceps
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Outer Box UPN: M00513363
- Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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