# FDA recall Z-2177-2023

> **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 PACK, Model Number DYNDH1306;   b)	BRST BX TRAY, Model Number DYNDH1389B;   c)	PLASTIC PACK, Model Number DYNJ35262A;   d)	VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A;   e)	FACELIFT PACK, Model Number DYNJ55954C;   f)	BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893;   g)	BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A;   h)	PLASTIC FREE FLAP, Model Number DYNJ67367;   i)	MAJOR BREAST PACK, Model Number DYNJ67381;   j)	RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B;   k)	DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250;   l)	PK GEN BREAST RESTON, Model Number DYNJ84305;   m)	BREAST, Model Number DYNJ904598B;   n)	MINOR BREAST, Model Number DYNJ905002B;   o)	MAJOR BREAST, Model Number DYNJ905004B;   p)	MAJOR BREAST, Model Number DYNJ905004C;   q)	MAJOR BREAST, Model Number DYNJ908890;   r)	MAJOR BREAST, Model Number DYNJ908890A;   s)	MINOR BREAST, Model Number DYNJ90

## 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-2177-2023
- **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-2177-2023

## Citation

> AI Analytics. FDA recall Z-2177-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2177-2023. Source: US FDA. Licensed CC0.

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