# FDA recall Z-2301-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-15.

## Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:   a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D;     b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J;   c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G;   d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C;   e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567;   f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N;   g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880;   h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS983394K;   i. ENDOVASCULAR IMF 88370-LF, Model Number: DYNJVB91067;   j. ENDOVASCULAR KIT, Model Number: DYNJ906354D, DYNJ906354F;   k. ENDOVASCULAR PACK, Model Number: DYNJ0678934I, DYNJ44934F, DYNJ905726C, DYNJ905726D;   l. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831F;   m. ENDOVASCULAR -TEMPLE, Model Number: DYNJ67750, DYNJ67750A, DYNJ67750B, DYNJ67750C

## Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

## Key facts

- **Recall number:** Z-2301-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-08-09

- **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-2301-2023

## Citation

> AI Analytics. FDA recall Z-2301-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2301-2023. Source: US FDA. Licensed CC0.

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