RegWardenFDA facility compliance records
Recall

Class II — Hamilton Medical, Inc.

Recalling firmHAMILTON MEDICAL, INC.
Registered facilityHAMILTON MEDICAL, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonCustomer reports that the ventilator display can freeze. Ventilation continues but the information is no longer displayed on the screen and the user can no longer operate the device.
ProductHamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
Quantity248
DistributionNationwide Distribution
Initiated2015-03-24
Classified2015-07-24
Terminated2015-12-23
Recall numberZ-2057-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Hamilton Medical, Inc. (Z-2057-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71234/

Not open yet

Alerts for HAMILTON MEDICAL, 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.

Planned

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.