The Recall Desk
HighFDA (Devices)·Z-0356-2025·Announced 2024-11-20

UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling

MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.

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: FDA Class II recall where specimen containers are non-sterile despite sterile labeling. While no illnesses have been reported, this poses a risk of sample contamination leading to diagnostic errors and potential for unnecessary treatment or prolonged hospitalization.

Plain-English summary

Medline Industries is recalling 626,305 UA Kit units (SKU DYKM1690A) distributed across the United States. The specimen containers included in these kits are labeled as sterile but have been identified to be non-sterile.

Non-sterile specimen containers pose a risk of sample contamination during collection and handling. Contaminated specimens can lead to inaccurate test results, potentially resulting in unnecessary medical treatment or prolonged hospitalization due to incorrect diagnoses.

The recalled kits were distributed nationwide to healthcare facilities in Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia, and Washington. The affected lot numbers are: 19KAA457, 19LAB178, 20FAB341, 20IAA286, 20WBC414, 21CBK056, 21EBG180, 21HBC490, 21KBB192, 22ABJ687, 22DBO057, 22GBO519, 22IBB016, 22LBC924, 23BBN989, 23EBF212, 23GBA753, 23IBD142, 23LBJ724, 24BBI191, 24FBC575, 24GBX259.

Healthcare facilities should identify and cease use of the affected lot numbers immediately and contact Medline Industries for replacement or quarantine procedures.

The recalled product

Product
UA KIT, SKU DYKM1690A; Component No. 503581
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Specimen Collection Kit
Hazard
  • non-sterile
  • contamination

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 (1)

  • UDI-DI: 40193489744201 (Case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category