# FDA recall Z-2205-2023

> **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)	TOTAL JOINT, Model Number CDS985555S;   b)	TOTAL KNEE, Model Number CDS985566Q;   c)	MAJOR ORTHO-LF, Model Number DYNJ0949139I;   d)	BSHR TOTAL KNEE-LF, Model Number DYNJ24525K;   e)	BSHR TOTAL HIP-LF, Model Number DYNJ24526P;   f)	TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L;   g)	TOTAL KNEE PACK 319735, Model Number DYNJ44635I;   h)	HIP ARTHROPLASTY PACK, Model Number DYNJ50072F;   i)	LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L;   j)	TOTAL JOINT, Model Number DYNJ57827D;   k)	ANTERIOR HIP PACK, Model Number DYNJ59126B;   l)	TOTAL HIP PACK, Model Number DYNJ60918A;   m)	MAIN TOTAL JOINT, Model Number DYNJ61376C;   n)	TOTAL HIP PACK, Model Number DYNJ63383;   o)	ANTERIOR PACK, Model Number DYNJ64814A;   p)	TOTAL JOINT PACK, Model Number DYNJ64951;   q)	TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B;   r)	TOTAL KNEE PACK-CSC, Model Number DYNJ65108F;   s)	MERCY ANTERIOR HIP, Model N

## 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-2205-2023
- **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-2205-2023

## Citation

> AI Analytics. FDA recall Z-2205-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2205-2023. Source: US FDA. Licensed CC0.

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