Medline Convenience Kits containing select SKUs of 10mL Polycarbonate… — Class II medical device recall Z-1884-2026
Ongoing recall by Medline Industries, LP, reported 2026-04-29, distributed nationwide. Unapproved design changes to the products outside of the 510(k) clearance.
| Recall number | Z-1884-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, CA, PA |
| Quantity | 270,311 total |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 10193489222555, 10193489227376, 10193489459364, 10193489631784, 10193489760002, 10193489783490, 10193489789164, 10195327131203, 10195327481506, 10195327507923, 10889942825103, 40193489222556, 40193489227377, 40193489459365, 40193489631785, 40193489760003, 40193489783491, 40193489789165, 40195327131204, 40195327481507, 40195327507924, 40889942825104 |
| Lot numbers | 20BBX692, 20DBC089, 20DBO375, 20EBG816, 20FBR153, 20GBC317, 20GBJ719, 20HBC159, 20HBD815, 20HBF519, 20HBN288, 20IBA514, 20IBK578, 20KBW291, 21ABW861, 21ALA437, 21AMA919, 21AMB491, 21BBB266, 21BBF218, 21BLA158, 21BLA178, 21BLA238, 21BLA352, 21BMC178, 21CBE230, 21CBW198, 21CBY118, 21CLA034, 21CLA516, 21DBL972, 21DBN140, 21DBV018, 21DLA700, 21EBS508, 21FBH674, 21FBK452, 21FLA184, 21FLA910, 21GBA227 and 204 more |
| Model numbers | DYNJ44027FQVH |
Product
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176
Reason for recall
Unapproved design changes to the products outside of the 510(k) clearance.
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-1884-2026. 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.