# FDA recall Z-1835-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-02-25.

## Product

Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F;  2) IR PACK, Model Number: DYNDH2104;  3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M;  4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078;  5) CATH PACK, Model Number: DYNJT4190;  6) ANGIO VASCULAR PACK, Model Number: DYNJT5717;  7) HEART CATH PACK, Model Number: DYNJ0381139R;  8) CARDIAC CATH PACK, Model Number: DYNJ04529L;  9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L;  10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J;  11) CATH TRAY #2, Model Number: DYNJ24706D;  12) CATH LAB PACK, Model Number: DYNJ24802Q;  13) CATH PACK, Model Number: DYNJ30268K;  14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R;  15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D;  16) CATH PACK-LF, Model Number: DYNJ33061D;  17) CATH PACK, Model Number: DYNJ34638K;  18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C;  19) CATH PACK, Model Number: DYNJ40904G;  20) CARDIAC CATH-LF, Model Number: DYNJ41057D;  21) CATH LAB PACK, Model Numb

## Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1835-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-25
- **Report date:** 2026-04-29

- **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-1835-2026

## Citation

> AI Analytics. FDA recall Z-1835-2026. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1835-2026. Source: US FDA. Licensed CC0.

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