Medline Urology Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling five models of urology convenience kits due to calibration issues in sterilization and packaging equipment that may compromise sterility assurance.
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 explicitly states all products were exposed to validated sterilization and packaging cycles; the hazard is a potential impact to sterility assurance, not confirmed sterility failure or reported infections. No illnesses or injuries are reported, making this a precautionary recall with theoretical risk.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits for urology use, including sling kits, penile repair kits, and peripheral stimulation kits. The recall affects five product models: DYKMBNDL106, DYKMBNDL106A, DYKMBNDL188, DYKMBNDL189, and DYKMBNDL189A, totaling 59 units distributed nationwide.
The recall has been initiated because Medline identified calibration issues in the equipment used to sterilize and package these devices. Although all products were exposed to validated sterilization and packaging cycles, the identified calibration issues have the potential to impact the sterility assurance level of the recalled products.
Consumers who have received these kits should contact Medline Industries for guidance on the recalled devices. Specific lot numbers and UDI identifiers for all affected units have been identified and are available through the FDA and the manufacturer.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Urology Kits
- Affected units
- 59
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) DYKMBNDL106
- UDI-DI: 10193489479294(each)
- 40193489479295(case)
- Lot Number: 21ABJ542
- 2) DYKMBNDL106
- Lot Number: 21BBG085
- 3) DYKMBNDL106A
- UDI-DI: 10193489880816(each)
- 40193489880817(case)
- Lot Number: 21KLA631
- 4) DYKMBNDL106A
- Lot Number: 22ALA713
- 5) DYKMBNDL106A
- Lot Number: 22BLB059
- 6) DYKMBNDL106A
- Lot Number: 22CLA049
- 7) DYKMBNDL188
- UDI-DI: 10193489478549(each)
- 40193489478540(case)
- Lot Number: 21ABS539
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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