# FDA recall Z-1461-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-02-11.

## Product

Medline procedure kits labeled as:   1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C;   2) BLEPH/RHINO PACK, Pack Number DYNJ64669A;   3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C;   4) DENTAL PACK, Pack Number DYNJ54064;   5) EAR PACK, Pack Number DYNJ68678C;   6) ENT HEAD NECK PACK, Pack Number DYNJ49023D;   7) ENT PACK, Pack Number DYNJ42564B;   8) ENT PACK, Pack Number DYNJ50572;   9) ENT PACK, Pack Number DYNJ45175B;   10) ENT PACK, Pack Number DYNJ65585A;   11) EP PACK, Pack Number DYNJ59171;   12) FUNCTIONAL ENDO SINUS WEILER, Pack Number DYNJ58857A;   13) HEAD & NECK, Pack Number DYNJ902987F;   14) HEAD & NECK PACK, Pack Number DYNJ61295B;   15) HEAD & NECK PACK, Pack Number DYNJ30234B;   16) HEAD & NECK PACK, Pack Number DYNJ50383;   17) HEAD & NECK PACK, Pack Number DYNJ36634K;   18) HEAD & NECK PACK, Pack Number DYNJ66399;   19) HEAD AND NECK PACK-LF, Pack Number DYNJ38402I;   20) MAJOR ENT HARPER PACK-LF, Pack Number DYNJ0161710I;   21) NASAL SINUS PACK-LF, Pack

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1461-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-11
- **Report date:** 2025-04-02

- **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-1461-2025

## Citation

> AI Analytics. FDA recall Z-1461-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-1461-2025. Source: US FDA. Licensed CC0.

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