EcoGel 100 Imaging Gel — Class I medical device recall Z-2480-2021
Ongoing recall by AMTEC SALES Inc, reported 2021-09-29, distributed nationwide. Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
| Recall number | Z-2480-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMTEC SALES Inc, Miami, FL, United States |
| Recall initiated | 2021-08-12 |
| Classified | 2021-09-22 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, DO, GT, HN, PA, SV |
| Quantity | 34,586 units |
| Reason classes | microbial contamination |
| Model numbers | 1000033, 3113545, 3158655, 3541420, 3874672, 6115004, 7565432 |
Product
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
Reason for recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2480-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.