# FDA recall Z-1366-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-12-31.

## 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 Nu

## 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.

## Distribution

Worldwide distribution - US Nationwide and the country of Bahamas.

## Key facts

- **Recall number:** Z-1366-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-31
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1366-2026

## Citation

> AI Analytics. FDA recall Z-1366-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1366-2026. Source: US FDA. Licensed CC0.

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