Medline Admit Kit DYKA1343A Medical Device Recall
Medline is recalling Admit Kits (Model DYKA1343A) due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the devices.
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. The source text states no actual illnesses or injuries have been reported, and the hazard is potential impact to sterility assurance level rather than an imminent or confirmed safety failure. Therefore, it qualifies as Moderate per the rubric criterion for low-risk or precautionary recalls.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, specifically the Admit Kit, Model Number DYKA1343A. The recall affects 1,090 units distributed nationwide in the US.
Medline identified calibration issues with the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization and packaging cycles, the calibration problems have the potential to impact the sterility assurance level (SAL) of the recalled products.
Consumers who have received these products should contact Medline Industries, LP for instructions on appropriate action. The affected lot numbers are: 21CBV232, 21IBB933, 21IBE395, 21JBF397, 22ABE640, 22EBK467, 22KBA245, 22LBR618, 23CBE825, 23EBC552, 23HBP415, 24BBV821, 24DBK171, 24IBD021, 25DBK346, 25FBN781, 25HBG194, and 25LBC732.
The recalled product
- Product
- Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
- Manufacturer
- Medline Industries, LP
- Affected units
- 1,090
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) DYKA1343A
- UDI-DI: 10193489312966(each)
- 40193489312967(case)
- Lot Number: 21CBV232
- 2) DYKA1343A
- Lot Number: 21IBB933
- 3) DYKA1343A
- Lot Number: 21IBE395
- 4) DYKA1343A
- Lot Number: 21JBF397
- 5) DYKA1343A
- Lot Number: 22ABE640
- 6) DYKA1343A
- Lot Number: 22EBK467
- 7) DYKA1343A
- Lot Number: 22KBA245
- 8) DYKA1343A
- Lot Number: 22LBR618
- 9) DYKA1343A
- Lot Number: 23CBE825
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 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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