# FDA recall Z-2191-2023

> **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)	CRANIOTOMY CDS-1, Model Number CDS982889I;   b)	JOINT INJECTION TRAY, Model Number DYNDH1722;   c)	LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X;   d)	ARTHROSCOPY PACK, Model Number DYNJ44322I;   e)	SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348D;   f)	SHOULDER ARTHROSCOPY PACK, Model Number DYNJ44348F;   g)	IR ARM PACK, Model Number DYNJ50712C;   h)	HYBRID PACK, Model Number DYNJ56907D;   i)	TUNNEL PACK, Model Number DYNJ58127B;   j)	CRANIOTOMY PACK, Model Number DYNJ61749A;   k)	CARPAL TUNNEL KIT, Model Number DYNJ63149A;   l)	ANGIOGRAPHY PACK, Model Number DYNJ65963A;   m)	ARTHROSCOPY PACK, Model Number DYNJ66402;   n)	ARTHROSCOPY PACK, Model Number DYNJ66402A;   o)	ARTHROSCOPY PACK, Model Number DYNJ66402C;   p)	SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404;   q)	SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404A;   r)	SHOULDER ARTHROSCOPY PACK, Model Number DYNJ66404B;   s)	ARTH

## 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-2191-2023
- **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-2191-2023

## Citation

> AI Analytics. FDA recall Z-2191-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2191-2023. Source: US FDA. Licensed CC0.

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