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.
What this means for you
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. Radia
- 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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