Reported Sep 20, 2023 · Ongoing

procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿…

Advance Medical Designs, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advance Medical Designs, Inc. · 1241 Atlanta Industrial Dr · Marietta, GA · 30066-6606

Is this the product you have?

  • procedural kits containing ultrasonic transmission gel
  • Item Numbers
    • a)¿¿¿¿¿ 28-GG023
    • b)¿¿¿¿ 28-GG105
    • c)¿¿¿¿¿ 28-GG107
    • d)¿¿¿¿ 28-GG121
    • e)¿¿¿¿ 28-GG219
    • f)¿¿¿¿¿¿ 28-GG223
    • g)¿¿¿¿¿ 28-GG303
    • h)¿¿¿¿ 28-GG307
    • i)¿¿¿¿¿¿ 28-GG519
    • j)¿¿¿¿¿¿ 28-GG519PC
    • k)¿¿¿¿¿ 28-GG521
    • l)¿¿¿¿¿¿ 28-GG521PC
    • m)¿¿¿ 28-GG529
    • n)¿¿¿¿ 28-GG553
    • o)¿¿¿¿ 28-GG569
    • p)¿¿¿¿ 28-GG571
    • q)¿¿¿¿ 28-GG723
Lot codes and dates

17 of 17 products

Products covered by this recall
#Product as published
120794C0208
2¿¿¿¿ 28-GG105, Lot Numbers: 21123C2346
3¿¿¿¿¿ 28-GG107, Lot Numbers: 21039C2325
4¿¿¿¿ 28-GG121, Lot Numbers: 21125C2346
5¿¿¿¿ 28-GG219, Lot Numbers: 30440C2419
6¿¿¿¿¿¿ 28-GG223, Lot Numbers: 21120C2341
7¿¿¿¿¿ 28-GG303, Lot Numbers: 10484C1000
8¿¿¿¿ 28-GG307, Lot Numbers: 20599C2238
9¿¿¿¿¿¿ 28-GG519, Lot Numbers: 20599C2238
10¿¿¿¿¿¿ 28-GG519PC, Lot Numbers: 20709C2256
11¿¿¿¿¿ 28-GG521, Lot Numbers: 21126C2346
12¿¿¿¿¿¿ 28-GG521PC, Lot Numbers: 21128C2346
13¿¿¿ 28-GG529, Lot Numbers: 20783C0208
14¿¿¿¿ 28-GG553, Lot Numbers: 10486C1000, 20816C2280
15¿¿¿¿ 28-GG569, Lot Numbers: 21124C2346
16¿¿¿¿ 28-GG571, Lot Numbers: 30502C2449
17¿¿¿¿ 28-GG723, Lot Numbers: 30502C2449
Amount recalled
1880 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Why it was recalled

Ultrasound gel mislabeled with inappropriate use.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:41 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.