Medline brand medical procedure convenience kits — Class II medical device recall Z-0164-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0164-2025 |
|---|---|
| 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 | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 8,830 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10195327043063, 10195327149710, 10195327149888, 10195327149918, 10195327149925, 10195327387365, 10195327387884, 10195327388003, 10195327388058, 10195327388065, 40195327043064, 40195327149711, 40195327149889, 40195327149919, 40195327149926, 40195327387366, 40195327387885, 40195327388004, 40195327388059, 40195327388066 |
| Lot numbers | 23KBE406, 23KBF923, 23KBK538, 23KBU812, 23LBH302, 23LBK182, 23LBK183, 23LBL067, 23LBL068, 23LBO854, 23LBP852, 24ABA832 |
| Model numbers | DYND150200S, DYND150216CS, DYND150216S, DYND150218CS, DYND150218S, DYND150816, DYND150816CS, DYND150816S, DYND150818CS, DYND150818S |
Product
Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; e) TRAY FOL LATX UM COUD 18FR MF, REF DYND150218CS; f) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; g) TRAY FOLEY LTX 18FR 10ML UM MF, REF DYND150218S; h) TRAY FOLEY SIL 16FR 10ML W/UM, REF DYND150816; i) TRAY FOL SIL UM COUD 16FR MF, REF DYND150816CS; j) TRAY FOL SIL 16FR 10ML W/UM MF, REF DYND150816S; k) TRAY FOL SIL UM COUD 18FR MF, REF DYND150818CS; l) TRAY FOL SIL 18FR 10ML W/UM MF, REF DYND150818S
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0164-2025. 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.