FDA Device recall Z-3126-2026
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193
- FDA Device
- Class I
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class I recall of Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193 by Medline Industries, citing the kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergill….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3126-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-11 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Reason
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Identifiers
| code_info | 1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 108899424…1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3126-2026%22
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