URINE COLLECTION KIT — Class II medical device recall Z-0358-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-11-20, distributed nationwide. Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-ter
| Recall number | Z-0358-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-23 |
| Classified | 2024-11-12 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 626,305 total |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10193489228144, 10193489438222, 10193489475548, 10193489863574, 10195327044121, 10195327132125, 10195327216689, 40193489228145, 40193489438223, 40193489475549, 40193489863575, 40195327044122, 40195327132126, 40195327216680 |
| Lot numbers | 19LAA062, 19LAA679, 19LAB089, 20AAA248, 20AAA946, 20KBQ534, 21ABL545, 21ABL580, 21DBG554, 21DBP497, 21ELA493, 21FLA001, 21FLA001Z, 21GLA397, 21GLA835, 21IBC805, 21JBC048, 21JBE414, 21JBM540, 21JBN917, 21JBX167, 21KBK233, 21KBN889, 21LBJ354, 21LBJ398, 21LBR785, 22BBG465, 22DLA811, 22DLA903, 22EBU527, 22ELA725, 22ELA923, 22FBC688, 22GLB140, 22GMH357, 22HLA173, 22HLA458, 22HLB334, 22IMG479, 22JBK244 and 41 more |
Product
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0358-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.