Medline ENT and Vascular Kits with Rescinded Regulatory Clearances
Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.
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 with no reported illnesses or injuries. The rescission of regulatory clearances indicates a regulatory/documentation issue rather than an immediate safety hazard, making this a moderate precautionary recall.
Plain-English summary
Medline Industries, LP is recalling three medical kits that were distributed nationwide: ENT PACK (Model DYNJ59030B), ENT (Model DYNJ908586C), and LH 3 PORT W/O WASTEBAG (Model VASC1081C). A total of 513 units are affected.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing components within these kits have been rescinded.
Healthcare providers and facility staff who have received these kits should stop using them. Customers with questions or who believe they have received affected units should contact Medline Industries, LP. Lot numbers and UDI identifiers are available on the FDA website for verification.
The recalled product
- Product
- Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG, Model Number: VASC1081C
- Manufacturer
- Medline Industries, LP
- Affected units
- 513
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)
- 1) DYNJ59030B
- UDI-DI: 10198459176920(each)
- 40198459176921(case)
- Lot Number: 24KBL574
- 2) DYNJ908586C
- UDI-DI: 10198459058677(each)
- 40198459058678(case)
- Lot Number: 24IBJ666
- 3) DYNJ908586C
- Lot Number: 24JBM014
- 4) DYNJ908586C
- Lot Number: 24KBE220
- 5) DYNJ908586C
- Lot Number: 24LBJ174
- 6) DYNJ908586C
- Lot Number: 25ABW145
- 7) DYNJ908586C
- Lot Number: 25CBK525
- 8) DYNJ908586C
- Lot Number: 25EBA897
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 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.
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