# FDA recall Z-1597-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-03-03.

## Product

Medline Convenience kits used for various procedures:  1) T   A PACK, Model Number: DYNJ67791A;   2) NASAL PACK, Model Number: DYNJ66514;   3) ENT PACK, Model Number: DYNJ67775A;   4) T/A ENDO PACK, Model Number: DYNJ83158;   5) T & A PACK, Model Number: DYNJ0634878I;   6) PPM-ICD PACK-LF, Model Number: DYNJ15949D;   7) TONSIL PACK, Model Number: DYNJ44525C;   8) ENT TRAY, Model Number: DYNJ44391K;   9) ENT PACK, Model Number: DYNJ49300D;   10) NASAL PACK, Model Number: DYNJ61555B;   11) HEAD AND NECK, Model Number: DYNJ57287A;   12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F;   13) ENT PACK, Model Number: DYNJ54035B;   14) ENT PACK, Model Number: DYNJ36516;   15) FESS PACK, Model Number: DYNJ59502B;   16) T AND A PACK, Model Number: DYNJ80790;   17) PK,ENT, Model Number: DYNJ57583;   18) ENT/LAP PACK, Model Number: DYNJ84876;   19) TONSIL PACK, Model Number: DYNJ50109B;   20) TONSIL, Model Number: DYNJ908452C;   21) CSS SINUS PACK, Model Number: DYNJ17005I;   22) ENT, Model Number: 

## Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

## Key facts

- **Recall number:** Z-1597-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-23

- **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-1597-2025

## Citation

> AI Analytics. FDA recall Z-1597-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1597-2025. Source: US FDA. Licensed CC0.

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