The Recall Desk
HighFDA (Devices)·Z-0358-2025·Announced 2024-11-20

Medline Urine Collection Kits Recalled Due to Non-Sterile Specimen Containers

Medline Industries recalls 626,305 urine collection kits with non-sterile specimen containers labeled as sterile. The kits may cause unnecessary treatment or prolonged hospitalization.

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: Class II device with non-sterile specimen containers in medical kits, presenting a risk of infection and contamination. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Medline Industries, LP is recalling 626,305 urine collection kits for containing non-sterile specimen containers despite being labeled as sterile. The kits were distributed nationwide in Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington.

The recall affects multiple product variants, including SKUs DYKM1848A, DYKM2005, DYKM2151, DYLAB1004, DYLAB1004A, DYLAB1006, and DYLAB1012. Specific lot numbers have been identified for each SKU and are detailed in the FDA recall notice.

Non-sterile specimen containers can lead to unnecessary medical treatment and prolonged hospitalization. As of the recall notice, no illnesses or injuries have been reported.

The recalled product

Product
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Specimen Collection
Hazard
  • non-sterile-container
  • infection-risk

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 (9)

  • SKU DYKM1848A - UDI/DI: 40193489228145 (Case)
  • 10193489228144 (Ea) - Lots: 19LAA062 19LAA679 19LAB089 20AAA248 20AAA946
  • SKU DYKM2005 - UDI/DI: 40193489475549 (Case)
  • SKU DYKM2151 - UDI/DI: 40195327132126 (Case)
  • 10195327132125 (Ea) - Lots: 24EMG654 24IMA511
  • SKU DYLAB1004 - UDI-DI: 40193489438223 (Case)
  • 10195327216689 (Ea) - Lots: 22GMH357 22IMG479
  • SKU DYLAB1006 - UDI/DI: 40193489863575 (Case)
  • SKU DYLAB1012 - UDI/DI: 40195327044122 (Case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category