# FDA recall Z-2186-2023

> **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)	VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121G;   b)	DBS PACK-LF, Model Number DYNJ0878178J;   c)	DBS PACK-LF, Model Number DYNJ0878178K;   d)	NEURO ARTERIOGRAM PACK-LF, Model Number DYNJ0948060F;   e)	NEURO IR PACK, Model Number DYNJ35066I;   f)	NEURO IR PACK, Model Number DYNJ35066J;   g)	IR NEURO PACK, Model Number DYNJ39198L;   h)	IR NEURO PACK, Model Number DYNJ39198N;   i)	BASIC PACK, Model Number DYNJ39752A;   j)	C.I.C.N. ANGIO PACK, Model Number DYNJ53064B;   k)	ANGIOGRAPHIC PACK, Model Number DYNJ57442C;   l)	ANGIO/VENO PACK, Model Number DYNJ58346A;   m)	NEURO RADIOLOGY PACK, Model Number DYNJ59903A;   n)	NEURO RADIOLOGY PACK, Model Number DYNJ59903B;   o)	PACK PERCUTANEOUS ANGIO  CHRG, Model Number DYNJ60112A;   p)	NEURO IR PACK, Model Number DYNJ60701D;   q)	RADIOLOGY NEURO DRAPE PAC, Model Number DYNJ61449;   r)	NEURO PACK, Model Number DYNJ61798D;   s)	BASIC CATH/ANGIO, Mode

## 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-2186-2023
- **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-2186-2023

## Citation

> AI Analytics. FDA recall Z-2186-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2186-2023. Source: US FDA. Licensed CC0.

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