The Recall Desk
Severity pendingFDA (Devices)·Z-1416-2026·Announced 2026-02-25

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING,

Pending LLM rewrite. Source: FDA_DEVICE Z-1416-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

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 S
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

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: 21BBG085
  • 2) DYKMBNDL106
  • Lot Number: 21ABJ542
  • 3) DYKMBNDL106A
  • UDI-DI: 10193489880816(each)
  • 40193489880817(case)
  • Lot Number: 22CLA049
  • 4) DYKMBNDL106A
  • Lot Number: 22BLB059
  • 5) DYKMBNDL106A
  • Lot Number: 22ALA713
  • 6) DYKMBNDL106A
  • Lot Number: 21KLA631
  • 7) DYKMBNDL188
  • UDI-DI: 10193489478549(each)
  • 40193489478540(case)
  • Lot Number: 21CBS043

Distribution

Distributed nationwide across the United States.

Related recalls

Same category