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# Avanos Pays $22 Million Over Misbranded Device
- URL: https://www.fdaweb.com/avanos-pays-22-million-over-misbranded-device/
- Published: 2021-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:05:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149685

Avanos Medical has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s fraudulent misbranding of its MicroCool surgical gowns. According to the [Justice Department](https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its?ref=fdaweb.com), Avanos falsely labeled the gowns as providing the highest level of protection against fluid and virus penetration. Additionally, an employee and an agent of Avanos obstructed a 7/2016 FDA for-cause inspection by making numerous false entries in four documents requested by agency investigators, it contends. Under the terms of a deferred prosecution agreement, Avanos will pay $22.2 million, comprising a victim compensation payment, a criminal monetary penalty, and a disgorgement payment.