# FDA recall Z-2170-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-18.

## Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)	BREAST BIOPSY KIT, Model Number DYNDA1224B;   b)	U/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)	BIOPSY PACK, Model Number DYNDH1124;   d)	REVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)	BREAST BIOPSY TRAY, Model Number DYNDH1266;   f)	BREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)	ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)	BASIC BIOPSY TRAY, Model Number DYNDH1534;   i)	ULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)	CABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)	BREAST BIOPSY TRAY, Model Number DYNDH1677;   l)	NORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)	SOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)	SOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)	UL BIOPSY TRAY, Model Number DYNDH1778;   p)	BREAST BIOPSY KIT, Model Number DYNDH1822;   q)	ULTRASOUND BIOPSY, Model Number DYNDH1828;   r)	BIOPSY PACK-LF, Model Number DYNJ0747885G;   s)	BIOPSY TRAY, Model Number

## Reason for recall

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

## Key facts

- **Recall number:** Z-2170-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-07-26

- **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-2170-2023

## Citation

> AI Analytics. FDA recall Z-2170-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2170-2023. Source: US FDA. Licensed CC0.

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