FDA Medical Device Recalls (openFDA)
Mac Medical Supply Co Inc: 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
- Recall number
- Z-2469-2021
- 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
- Status
- Open, Classified
- Initiated
- 2021-08-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
- 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, recall@macmed.com. To contact MAC Medical Supply directly with questions, call 800-523-8337, ask for recall coordinator.
- Quantity
- 100,114 units
- Distribution
- United States Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K955246"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3004963952
- Firm city
- Munster
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28