---
title: "Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-E... — FDA record Z-2536-2023 | Is It on Recall"
description: "Ultrasound gel mislabeled with inappropriate use."
url: https://isitonrecall.com/recall/fda-device-z-2536-2023-procedural-kits-containing-ultrasonic-transmission-gel-item-numbers-a-28-eg103-b-28-eg125-c-28-eg135/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG... — FDA record Z-2536-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
- **Reason**: Ultrasound gel mislabeled with inappropriate use.
- **Classification**: Class II
- **Recalling firm**: Advance Medical Designs, Inc.
- **Quantity**: 460 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2536-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2536-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274; |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US, Canada, UK, Panama, Netherlands

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Sep 20, 2023
- **Recall initiation date**: Jul 7, 2023
- **Center classification date**: Sep 8, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2536-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Advance Medical Designs, Inc. records](https://isitonrecall.com/brand/advance-medical-designs-inc/)