# FDA recall Z-2159-2023

> **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)	ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-401318M;   b)	ANGIOGRAPHY OR, Model Number CDS984944C;   c)	ANGIOGRAM, Model Number DYNJ0149444M;   d)	EP LAB DEVICE PACK-LF, Model Number DYNJ0160556D;   e)	VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AG;   f)	ANGIO PACK-LF, Model Number DYNJ0373279M;   g)	VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121I;   h)	IPMC ANGIOGRAPHY PACK-LF, Model Number DYNJ0806254D;  i)	ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485T;   j)	ANGIO DRAPE PACK, Model Number DYNJ17624B;   k)	DEPAUL ANGIO PACK, Model Number DYNJ19939M;   l)	EP ANGIOGRAPHY PACK, Model Number DYNJ24225K;   m)	ANGIOGRAPHY DRAPE PACK-LF, Model Number	DYNJ28067G;   n)	DASHTI-YAO NEURO ANGIO-LF, Model Number DYNJ33457C;   o)	ANGIOGRAM TRAY, Model Number DYNJ33638K;   p)	ANGIO PACK, Model Number DYNJ34361;   q)	ANGIO/PICC PACK, Model Number DYNJ36049;   r)	IR MINOR ANGIO PACK, Model Number	DYN

## 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-2159-2023
- **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-2159-2023

## Citation

> AI Analytics. FDA recall Z-2159-2023. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2159-2023. Source: US FDA. Licensed CC0.

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