Cook Inc. Recalls OptiLite Multi-Use Holmium Laser Fibers Due to Reprocessing Instructions
Cook Inc. is voluntarily recalling OptiLite Multi-Use Holmium Laser Fibers because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a documentation issue regarding reprocessing instructions, which fits the criteria for a moderate severity score involving minor labeling or documentation errors.
Plain-English summary
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers. These devices are supplied sterilized by ethylene oxide gas in peel-open packages and are used with the Odyssey 30 Holmium Laser System for the fragmentation of urinary calculi and soft tissue applications, including incision, excision, ablation, and coagulation.
The recall was initiated because it was identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The affected units were distributed worldwide, including nationwide in the United States and in various foreign countries. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units beyond the initiation of the recall.
The recalled product
- Product
- OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and…
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Laser Fiber
- Affected units
- 10,415
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 (18)
- OptiLite Multi-Use Holmium Laser Fibers
- Catalog Numbers followed by GPN: HLF-M273-CNV
- G48611 HLF-M273-SMA
- G48522 HLF-M365-CNV
- G48613 HLF-M365-SMA
- G48618 HLF-M550-CNV
- G48615 HLF-M550-SMA
- G48619 HLF-M940-CNV
- G48617 HLF-M940-SMA
- G48621 HLF-M273-CNV-CAN
- G51777 HLF-M273-SMA-CAN
- G51785 HLF-M365-CNV-CAN
- G51778 HLF-M365-SMA-CAN
- G51786 HLF-M550-CNV-CAN
- G51779 HLF-M550-SMA-CAN
- G51787 HLF-M940-CNV-CAN
- G51780 HLF-M940-SMA-CAN
- G51788
Distribution
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