Medline brand — Class II medical device recall Z-0155-2025
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-0155-2025 |
|---|---|
| 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 | 1,460 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10080196015412, 10193489395624, 10193489844801, 10195327040161, 10195327040178, 10195327104351, 10195327267926, 10884389905678, 10888277858626, 40080196015413, 40193489395625, 40193489844802, 40195327040162, 40195327040179, 40195327267927, 40884389905679, 40888277858627 |
| Lot numbers | 23KBE846, 23LBG513, 23LBK374, 23LBK443, 23LBL629, 23LBL780, 23LBL962, 23LBO852, 23LBU931 |
| Model numbers | DYNDH1609, DYNJ19010I, DYNJ29207, DYNJ43661C, DYNJ46746C, DYNJ47667C, DYNJ50712D, DYNJ67324, HCT093J |
Product
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J
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-0155-2025. 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.