Biopsy Forceps Recall: Sterile Packaging Breach Risk
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with risk-of-harm potential where injury has not yet been reported, meeting the High severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Boston Scientific Corporation is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging. The affected products include multiple configurations with specific UPNs, GTINs, and lot numbers as listed in the recall notice.
The recall affects 5,020 units distributed in the US and 20,770 units distributed outside the US. US distribution includes nationwide coverage in multiple states, with international distribution pending.
Healthcare facilities and users should immediately check their inventory for the affected lot numbers and UPNs. Any unused devices from the recalled lots should be quarantined and returned according to the recall instructions provided by Boston Scientific.
The recall was initiated due to the potential for sterile barrier breach, which could compromise the sterility of the devices and pose a risk to patients if used. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
- 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)
- 1. Outer Box UPN: M00513321
- Inner Box UPN: M00513330. GTIN: 08714729755494. Lot Number: 38519443.
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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