Boston Scientific Recalls MoXy Laser Fiber for Breakage Risk
Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.
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 typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a precautionary update to instructions to reduce the likelihood of breakage, without reporting specific injuries or deaths.
Plain-English summary
Boston Scientific Corporation is recalling MoXy Laser Fibers, Material Number 0010-2400. The product is used for surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue. The recall involves 146,633 units distributed worldwide, including nationwide distribution in the United States.
The recall is being conducted to reinforce existing instructions within the Directions for Use (DFU) and provide further guidance. This updated guidance is intended to reduce the likelihood of metal cap and fiber tip breakage related to temperature complaints.
Healthcare providers and consumers should check their inventory for the affected lot numbers listed in the recall notice. If the product is found, it should be removed from use pending further instructions from the manufacturer or the FDA.
The recalled product
- Product
- MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 146,633
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 (20)
- Lot Numbers: 21857621
- 21857622
- 2 1885 133
- 21885134
- 21911808
- 21918152
- 21933082
- 21955208
- 21966592
- 21972810
- 22012232
- 22012233
- 22045291
- 22045292
- 22075867
- 22075868
- 22102605
- 22133874
- 22133875
- 22164395
Distribution
Distributed nationwide across the United States.
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