The Recall Desk
HighFDA (Devices)·Z-0355-2025·Announced 2024-11-20

Medical Laboratory Kit Recalled Due to Non-Sterile Specimen Container

Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in 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: This recall is classified as High (Score 3) under FDA Class II designation. The hazard—non-sterile specimen containers in medical laboratory kits—represents a risk-of-harm product where injury has not yet been reported, as contaminated samples could lead to incorrect diagnostic results and unnecessary medical treatment. The source text states no illnesses or injuries have occurred.

Plain-English summary

Medline Industries, LP is recalling 626,305 medical laboratory kits (SKU DYLAB1018, Component No. 503581) nationwide. The specimen container included in these kits is labeled as sterile but has been identified to be non-sterile, creating a potential contamination risk.

The affected kits were distributed in the states of Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. The recalled lot is identified as 24IMC246. Facilities using these kits should check their inventory for the affected lot number.

Non-sterile specimen containers can allow contamination of samples, potentially leading to inaccurate test results, unnecessary medical treatment, or prolonged hospitalization. Healthcare facilities should review their records to determine if any patient care decisions were based on results from specimens processed using containers from the recalled kits.

Customers with affected units or with questions should contact Medline Industries for instructions on returns and replacement products.

The recalled product

Product
Lab Kit, SKU DYLAB1018; Component No. 503581
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Laboratory Equipment
Hazard
  • non-sterile
  • contamination-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 (2)

  • UDI-DI: 40195327088393 (Case)
  • 10195327088392 (Ea) Lots: 24IMC246

Distribution

Distributed nationwide across the United States.

Related recalls

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