# FDA recall Z-2169-2023

> **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)	FETAL SURGERY CDS-LF, Model Number CDS840214Q;   b)	MINOR PROCEDURE TRAY, Model Number DYNDA2418;   c)	CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J;   d)	BARIATRIC PACK, Model Number DYNJ24459P;   e)	ABLATION PACK, Model Number DYNJ40629B;   f)	ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B;   g)	IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C;   h)	EVLT SURGICAL PACK, Model Number DYNJ48520;   i)	MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A;   j)	LAPAROSCOPY PACK, Model Number DYNJ59813;   k)	PORT PACK, Model Number DYNJ61747C;   l)	RR-BRACHY PACK, Model Number DYNJ68027A;   m)	AV FISTULA PACK, Model Number DYNJ81410B;   n)	ECMO PACK-LF, Model Number DYNJ82517;   o)	SYNERGY PROCEDURE PACK, Model Number DYNJ83966;   p)	MINOR, Model Number DYNJ906915;   q)	PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C;   r)	ULTRASOUND PACK-LF, Model Number PHS751646C;   s)	UL

## 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-2169-2023
- **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-2169-2023

## Citation

> AI Analytics. FDA recall Z-2169-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2169-2023. Source: US FDA. Licensed CC0.

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