Recall archive / FDA device enforcement
URINE KIT, SKU DYKM1845; Component No. 503581 — FDA record Z-0360-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- URINE KIT, SKU DYKM1845; Component No. 503581
- Reason
- Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 626,305 Total Kits (US only)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0360-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI: 40193489713993 (Case), 10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 22DMI870 22FMA088 22HMH213 22JMH449 22LMH860 23CMA518 23CMG948 23DMG087 23EMH568 23GMD322 23HME585 23IMG193 23KMD763 24AMD430 24CMA930 24CMD335 24DMA485 24FMF320 24GMJ197 24IME270 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 20, 2024
- Recall initiation date
- Oct 23, 2024
- Center classification date
- Nov 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.