Z-2469-2021Class I

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic...

Name: Z-2469-2021 Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic...
Creator: Mac Medical Supply Co Inc
Published: 2021-08-04
License: https://open.fda.gov/license/

Mac Medical Supply Co Inc / initiated 2021-08-04 / Open, Classified / root cause: manufacturing process

FDA source

Mac Medical Supply Co Inc began a recall of Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical... on 2021-08-04. FDA classified it as Class I and gives the reason as "Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2469-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-04
Posted: 2021-09-17
Recalling firm: Mac Medical Supply Co Inc
Product: Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Email notification was made to consignees on 08/25-26/2021. The recall is extended to all customers which includes distributors, medical facilities, retail and users. Customers are asked to identify their impacted customers and forward the recall notification to those customers that have received impacted product. Customers are asked to destroy all affected product at their facility and return the recall response form. Customers are advised that destruction of product should render it unusable. Customers must contact MAC Medical Supply to confirm receipt of the notice and that they are proceeding with the recall via email, [email protected]. To contact MAC Medical Supply directly with questions, call 800-523-8337, ask for recall coordinator.
Quantity in commerce: 100,114 units
Distribution: United States Nationwide distribution.
Product codes and lots: Item Numbers: 1) 001205 (LiquaSonic Ultrasound Gel, 8.5oz) 2) 001222 (LiquaSonic Ultrasound Gel, 5L) 3) 30GB (EcoGel 100, 250ml, 12/cs) 4) 5005L4 (MAC EcoGel 5L, 4/cs) 5) 500812 (MAC EcoGel, 250ml, 12/cs) 6) M50008 (MediChoice Empty 8oz bottle) 7) M5005L4 (MediChoice USG 5L, 4/cs) 8) M500812 (MediChoice, 250ml, 12/cs) 9) 50TB (EcoGel High V TENS, 250ml) 10) 40JBB (EcoGel Multipurpose Ultrasound Gel, 250ml, 8oz, 12/cs) 11) 40JBHV-24 (EcoGel Blue High Velocity Ultrasound Gel, 250ml, 24/cs) 12) 40JMC (EcoGel 200 MultiPurpose Clear Ultrasound Gel 4-5ml Cubes with 4 dispenser bottles, 5L, 4/cs) 13) 20400 (MAC Ultrasound Gel Packet - Multipurpose) All lots shipped between 08/2018 and 08/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2469-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2469-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-17

Product code ITX

K955246Class IIEcogel 200 Ultrasound GelEco-Med Pharmaceuticals, Inc. / cleared 1996-02-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)