Medline Industries, LP: Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT URO

Company / brand

Medline Industries, LP

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 STIMULA, Model Number: DYKMBNDL189A

Reason / hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide distribution - US Nationwide.

Recall initiated

2026-01-07

Code info

1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521

Product quantity

59 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98329

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