Medline Convenience Kits with Polycarbonate Syringes Recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
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: This is an FDA Class II recall involving unapproved design changes to a medical device. The source text does not report any injuries or illnesses, making this a regulatory compliance issue rather than an immediate safety hazard, consistent with Class II classification criteria.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes (Lot 24ABR895, UDI-DI 10889942396856). The recall is due to unapproved design changes to the products that were made outside of the 510(k) clearance process.
The affected kits were distributed worldwide, including throughout the United States and to Canada, Panama, and Barbados. A total of 270,311 units are involved in this recall.
Consumers in possession of these syringes should discontinue use and contact Medline Industries for further instructions regarding return or replacement of the product.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 270,311
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)
- DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Medline Industries, LP 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.
See all 17 products in this recall →Related recalls
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