Medline Convenience Kits surgical packs sterilization calibration recall
Medline Industries is recalling three models of surgical convenience kits—Lithotomy Packs and Lap Basin—due to calibration issues with sterilization equipment that could affect the sterility assurance 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 with no reported injuries or illnesses. The hazard is a potential impact on sterility assurance due to equipment calibration issues, making this a precautionary manufacturing/quality issue rather than a confirmed contamination or direct harm scenario.
Plain-English summary
Medline Industries, LP is recalling 826 units of three models of Medline Convenience Kits: Lithotomy Pack Model DYNJ83185, Lithotomy Pack Model DYNJ83185A, and Lap Basin Model DYNJVB91109D, distributed nationwide in the US and worldwide.
Medline identified calibration issues with the equipment used to sterilize and package these 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.
The affected products include multiple lot numbers for each model. Healthcare providers and hospitals that have received these kits should not use them and should contact Medline for instructions on returns or replacements.
The recalled product
- Product
- Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
- Manufacturer
- Medline Industries, LP
- Affected units
- 826
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) DYNJ83185
- UDI-DI: 10195327247058(each)
- 40195327247059(case)
- Lot Number: 22LDA486
- 2) DYNJ83185
- Lot Number: 23CDA474
- 3) DYNJ83185
- Lot Number: 23CDB552
- 4) DYNJ83185
- Lot Number: 23FDC392
- 5) DYNJ83185A
- UDI-DI: 10195327468606(each)
- 40195327468607(case)
- Lot Number: 23HDB637
- 6) DYNJ83185A
- Lot Number: 24CDA984
- 7) DYNJ83185A
- Lot Number: 24CDB327
- 8) DYNJ83185A
- Lot Number: 24CDB829
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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