Medline Convenience Kits sterilization calibration issue recalled
Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.
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 does not report any illnesses, injuries, or confirmed sterility failures—only a potential impact on sterility assurance level from identified calibration issues. Per the rubric, a Class II recall with no reported adverse health consequences and a theoretical hazard falls under Moderate severity.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, Model Number DYNJ63118A (Lot Number 25ABV005), due to calibration issues identified in the equipment used to sterilize and package the devices. The company has determined that while all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Approximately 72 units of the recalled kit have been distributed nationwide in the United States and worldwide. Consumers who have purchased this product should discontinue use and contact Medline Industries, LP for further instructions regarding the recalled product.
The recalled product
- Product
- Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
- Manufacturer
- Medline Industries, LP
- Affected units
- 72
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 (4)
- 1) DYNJ63118A
- UDI-DI: 10195327644291(each)
- 40195327644292(case)
- Lot Number: 25ABV005
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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