Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns
Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.
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, and the hazard is a potential sterility compromise due to packaging defects. No illnesses or injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
Argon Medical Devices, Inc. is recalling 15 boxes of Harvest Needles (15GA x 2). These medical devices are intended for harvesting bone and/or bone marrow specimens. The recall was initiated after the firm received a customer complaint regarding a potential defect in the forming of the primary package of the blister. This defect may compromise the sterility of the product inside the tray.
The affected product is identified by lot number 11158857. The recall covers distribution in the United States (nationwide) and internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
Consumers and healthcare providers should stop using the affected Harvest Needles and contact Argon Medical Devices, Inc. for further instructions or a return.
The recalled product
- Product
- HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
- Manufacturer
- Argon Medical Devices, Inc
- Affected units
- 15
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 (1)
- lots: 11158857
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Argon Medical Devices, Inc 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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