FDA Device recall Z-0360-2025
URINE KIT, SKU DYKM1845
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of URINE KIT, SKU DYKM1845 by Medline Industries Northfield, citing 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 hos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0360-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-23 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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.
Identifiers
| code_info | UDI/DI: 40193489713993 (Case), 10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 2…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0360-2025%22
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