The Recall Desk
SevereFDA (Devices)·Z-1414-2026·Announced 2026-02-25

Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration

Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with potential to compromise sterility assurance of medical devices used in labor and delivery are classified as Severe (score 4), as they present a risk of serious health consequences if non-sterile devices are used in invasive procedures.

Plain-English summary

Medline Industries, LP is recalling 27,320 units of its labor and delivery convenience kits, including models such as OB KIT, LABOR DELIVERY TUBAL LIGAT, and various L&D and VAGINAL DELIVERY PACKS. The recall covers numerous model numbers and lot numbers, with worldwide distribution including US nationwide.

The recall is being issued because Medline identified calibration issues related to the equipment used to sterilize and package the devices. While all products were exposed to the validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.

Healthcare facilities and providers that received the affected kits should follow their organization's recall procedures and contact Medline Industries, LP for replacement or credit. Consumers or patients with questions about the recall should contact their healthcare provider.

The recall was classified by the FDA as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Numbe
Manufacturer
Medline Industries, LP
Category
Medical Device — Sterile Convenience Kits
Hazard
Affected units
27,320

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) DYKM2326
  • UDI-DI: 10198459565748(each)
  • 40198459565749(case)
  • Lot Number: 25KMF765
  • 2) DYKMBNDL165
  • UDI-DI: 10193489477405(each)
  • 40193489477406(case)
  • Lot Number: 24ABK386
  • 3) DYKMBNDL165
  • Lot Number: 23KBV905
  • 4) DYKMBNDL165
  • Lot Number: 23KBA329
  • 5) DYKMBNDL165
  • Lot Number: 23HBR548
  • 6) DYKMBNDL165
  • Lot Number: 23EBP170
  • 7) DYKMBNDL165
  • Lot Number: 23BBT994
  • 8) DYKMBNDL165
  • Lot Number: 22LBB693

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 hazard · sterility compromise

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