Z-2534-2023Class II

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Name: Z-2534-2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Creator: Advance Medical Designs, Inc.
Published: 2023-07-07
License: https://open.fda.gov/license/

Advance Medical Designs Inc / initiated 2023-07-07 / Open, Classified / root cause: labeling and UDI

FDA source

Advance Medical Designs, Inc. began a recall of Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 on 2023-07-07. FDA classified it as Class II and gives the reason as "Ultrasound gel mislabeled with inappropriate use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2534-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-07
Posted: 2023-09-09
Recalling firm: Advance Medical Designs Inc
Product: Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Ultrasound gel mislabeled with inappropriate use.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
Quantity in commerce: 26900 units
Distribution: US, Canada, UK, Panama, Netherlands
Product codes and lots: a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2534-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2532-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08
Z-2533-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08
Z-2534-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08
Z-2535-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08
Z-2536-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08
Z-2537-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-08

Product code ITX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)