Medline Industries IV Administration and Extension Sets: 1) DBD-IV… — Class II medical device recall Z-1366-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-25, distributed nationwide. Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors
| Recall number | Z-1366-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-31 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS |
| Quantity | 926,227 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10197344008247, 10197344008254, 10197344076932, 10197344076949, 10197344076956, 10197344076963, 10197344076970, 10197344076987, 10197344076994, 10197344077007, 10197344098613, 10197344098620, 10197344098637, 10197344098644, 10197344098651, 10197344098668, 10197344105656, 10197344105663, 10197344105670, 10197344105687, 10197344105694, 10197344105700, 10197344105717, 20197344008244, 20197344008251 and 21 more |
| Model numbers | DYNDTB0512, DYNDTB0529, DYNDTB0555, DYNDTB1012, DYNDTB1022, DYNDTB1029, DYNDTB1045, DYNDTB1512, DYNDTB1516, DYNDTB1529, DYNDTB1530, DYNDTB1537, DYNDTB1539, DYNDTB1540, DYNDTB1545, DYNDTB1545D, DYNDTB2012, DYNDTB2022, DYNDTB2029, DYNDTB2045, DYNDTB2524, DYNDTB5077, DYNDTB5081 |
Product
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
Reason for recall
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
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-1366-2026. 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.