Ameda, Inc.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- Ameda, Inc. FEI 3009974348 · TX
Recalls & enforcement
- Class IIIOngoing2017-07-10Two specific lots was incorrectly manufactured containing a UK power adapter.
- Class IITerminated2015-02-12Devices were not sterilized
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Ameda, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10042362-ameda-inc/
Alerts for Ameda, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.