CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report

Procedural kits containing ultrasonic transmission gel recalled

Advance Medical Designs is recalling Procedural kits containing ultrasonic transmission gel. The recall was initiated on 7 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

Quantity recalled26900 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2534-2023
FDA event ID: 92735
Recalling firm: Advance Medical Designs, Marietta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Jul 2023
FDA classified: 8 Sep 2023
Reported: 20 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

7 Jul 2023	Recall initiated by company
8 Sep 2023	Classified by FDA	+63 days
20 Sep 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Ultrasound gel mislabeled with inappropriate use.

Product as listed by the FDA

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

Where it was distributed

US, Canada, UK, Panama, Netherlands

Questions about this recall

Why was it recalled?

Ultrasound gel mislabeled with inappropriate use.

Which lots are affected?

a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

Where was it sold?

US, Canada, UK, Panama, Netherlands

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 92735

This product is part of a recall event; the main page for the event is ASG-001; Ultrasound gel recalled by Advance Medical Designs.

Reported	Class	Recall	Company	Reason	Where
20 Sep 2023	CLASS II	ASG-001; Ultrasound gel recalled by Advance Medical Designs	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023	CLASS II	50-GEL20; Ultrasound gel recalled by Advance Medical Designs	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023	CLASS II	Procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023	CLASS II	Procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023	CLASS II	procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA

More recalls from Advance Medical Designs

All 6

Reported	Class	Recall	Company	Reason	Where
20 Sep 2023Device	CLASS II	procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023Device	CLASS II	Procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023Device	CLASS II	Procedural kits containing ultrasonic transmission gel recalled	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023Device	CLASS II	50-GEL20; Ultrasound gel recalled by Advance Medical Designs	Advance Medical Designs	Labeling Errors	GA
20 Sep 2023Device	CLASS II	ASG-001; Ultrasound gel recalled by Advance Medical Designs	Advance Medical Designs	Labeling Errors	GA

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