# FDA recall Z-2165-2023

> **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)	EP PACER PACK, Model Number DYNJ67770A;  b)	EP PROCEDURE PACK, Model Number DYNJ67771;  c)	EP PACK, Model Number DYNJ68019;  d)	GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198;  e)	TAVR PACK, Model Number DYNJ68499B;  f)	VEIN CLINIC, Model Number DYNJ68667;  g)	VASCULAR PACK, Model Number DYNJ68863;  h)	VASCULAR PACK, Model Number DYNJ68880;  i)	TAVR PACK, Model Number DYNJ68933;  j)	PROCEDURE PACK, Model Number DYNJ68968A;  k)	PORT PACK, Model Number DYNJ68990A;  l)	STROKE PACK, Model Number DYNJ69009A;  m)	ENDOVENOUS BASIC PACK, Model Number DYNJ69108A;  n)	VEIN ABLATION KIT, Model Number DYNJ69272A;  o)	UPPER ENDOVASCULAR PK, Model Number DYNJ69302;  p)	STROKE PACK, Model Number DYNJ69422;  q)	UNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622;  r)	UNM ACCESS PACK, Model Number DYNJ69624;  s)	FLUSHING VASCULAR CENTER, Model Number DYNJ69626;  t)	AFIB PACK, Model Number DYNJ69682;  u)	ENDO

## 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-2165-2023
- **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-2165-2023

## Citation

> AI Analytics. FDA recall Z-2165-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2165-2023. Source: US FDA. Licensed CC0.

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