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

Urology kits recalled over sterilization equipment calibration issues

Medline is recalling 59 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the calibration issues have the potential to impact the sterility assurance level of products used in sterile procedures, and no injuries are reported.

Plain-English summary

Medline convenience kits are being recalled by Medline Industries, LP, covering Kit Urology Sling under model numbers DYKMBNDL106 and DYKMBNDL106A and Kit Urology Penile Repair under DYKMBNDL188, among the model numbers listed in the enforcement record.

The record states Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. It states 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 record lists 59 units, with model numbers, UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States. The FDA has classified the action as Class II.

A sterility assurance level that cannot be relied on carries an infection risk for products used in sterile procedures. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Medline's instructions.

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 — Procedure kit
Hazard
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: 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.

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.

See all 42 products in this recall →

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Same manufacturer · Medline Industries, LP

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Same hazard · sterility assurance

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