# FDA recall Z-2307-2023

> **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. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B;       b. BASIC BIOPSY TRAY, Model Number: DYNDH1534;     c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485;       d. BIOPSY PACK-LF, Model Number: DYNJ0747885G;       e. BIOPSY RAD CT, Model Number: DYNJ59752A;       f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690;       g. BIOPSY WITH PROB COVER WRO-LF, Model Number: DYNJ42307A;       h. BREAST BIOPSY KIT, Model Number: DYNDA1224B;       i. BREAST BIOPSY TRAY, Model Number: DYNDH1266, DYNDH1302, DYNDH1345A, DYNDH1677;       j. CABARRUS BIOPSY TRAY, Model Number: DYNDH1670;        k. CORE BIOPSY PACK-LF, Model Number: DYNJ42752A;       l. GENERAL BIOPSY PACK, Model Number: P365500;       m. IGT BIOPSY PACK-LF, Model Number: DYNJ38616A;       n. IR BIOPSY PACK, Model Number: DYNJ63688I;       o. PROSTATE BIOPSY, Model Numbe

## 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-2307-2023
- **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-2307-2023

## Citation

> AI Analytics. FDA recall Z-2307-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2307-2023. Source: US FDA. Licensed CC0.

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