Merit Medical Recalls Inflation Syringe Kits Due to Labeling Errors
Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.
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 due to missing required labeling information, which fits the rubric criterion for minor labeling errors or low-risk issues.
Plain-English summary
Merit Medical Systems, Inc. has announced a voluntary field action for the Merit Inflation Syringe Kit, Catalog Number KOS-02857. The recall involves 1,297 total units. The specific reason for the recall is that the unit labels are missing required device labeling information.
The affected products are identified by Lot Numbers H959038, H970334, and H984351. Distribution was limited to one consignee located in California. There were no shipments to Canada, other foreign countries, or VA/government/military consignees.
This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should stop using the affected syringe kits and contact Merit Medical Systems for further instructions.
The recalled product
- Product
- Merit Inflation Syringe Kit. Catalog Number KOS-02857
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 1,297
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 (3)
- Lot Numbers: H959038
- H970334
- H984351.
Distribution
Distributed in 1 state:
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