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
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-2536-2023
- 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) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
Where it was distributed
US, Canada, UK, Panama, Netherlands
Questions about this recall
Is Procedural kits containing ultrasonic transmission gel recalled?
Yes. Advance Medical Designs recalled Procedural kits containing ultrasonic transmission gel on 7 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2536-2023.
Why was it recalled?
Ultrasound gel mislabeled with inappropriate use.
Which lots are affected?
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;
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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