FDA Device recall Z-0355-2025
Lab Kit, SKU DYLAB1018
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Lab Kit, SKU DYLAB1018 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-0355-2025 |
| 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
Lab Kit, SKU DYLAB1018; 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: 40195327088393 (Case); 10195327088392 (Ea) Lots: 24IMC246 |
|---|
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-0355-2025%22
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