Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which involves a remote possibility of adverse health consequences.
Plain-English summary
Boston Scientific Corporation is recalling Radial Jaw 4 Standard Capacity Biopsy Forceps. The recall is being conducted due to a potential for a breach in the sterile barrier of the device packaging.
This recall affects specific models and lot numbers distributed nationwide in the United States and internationally. Affected products include Radial Jaw 4 SC 240cm (UPN M00513401, M00513402) and Radial Jaw 4 SC w/ Needle 240cm (UPN M00513411).
Distributors and healthcare providers should check their inventory for the affected lot numbers and contact Boston Scientific Corporation for further instructions.
The recalled product
- 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.…
- Manufacturer
- Boston Scientific Corporation
- Hazard
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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