# FDA recall Z-2166-2023

> **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)	SILVER CROSS OPEN HEART, Model Number DYNJ906102G;  b)	SILVER CROSS OPEN HEART, Model Number DYNJ906102I;  c)	CUSTOM CARDIAC CABG, Model Number DYNJ906108C;  d)	VASCULAR STENT INOVA, Model Number DYNJ906440A;  e)	CABG, Model Number DYNJ906878A;  f)	VALVE, Model Number DYNJ906882A;  g)	VASCULAR, Model Number DYNJ906883A;  h)	DR WILLIAMS HEART, Model Number DYNJ907552A;  i)	PUH PERCUTANEOUS ECMO, Model Number DYNJ907554C;  j)	TAVR, Model Number DYNJ907561A;  k)	TAVR, Model Number DYNJ907561B;  l)	TAVR, Model Number DYNJ907561C;  m)	OPEN HEART CDS, Model Number DYNJ907607A;  n)	OPEN HEART CDS, Model Number DYNJ907607B;  o)	OPEN HEART CDS, Model Number DYNJ907607C;  p)	OPEN VASCULAR UE, Model Number DYNJ907858A;  q)	PACEMAKER, Model Number DYNJ907907;  r)	DEBOER HEART, Model Number DYNJ907914A;  s)	DEBOER HEART, Model Number DYNJ907914B;  t)	DEBOER HEART, Model Number DYNJ907914C;  u)	GENERAL HEART, M

## 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-2166-2023
- **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-2166-2023

## Citation

> AI Analytics. FDA recall Z-2166-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2166-2023. Source: US FDA. Licensed CC0.

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