CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report

Hamilton-C3 Ventilator Unit recalled by Hamilton Medical AG

Hamilton Medical is recalling Hamilton-C3 Ventilator Unit, distributed in 9 states. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 3084, 3088

Quantity recalled2 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2796-2018
FDA event ID: 80467
Recalling firm: Hamilton Medical, Bonaduz
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2018
FDA classified: 13 Aug 2018
Reported: 22 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: CPAP & Ventilators

Timeline

9 Mar 2018	Recall initiated by company
13 Aug 2018	Classified by FDA	+157 days
22 Aug 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An out of specification component on the control board may cause the ventilator to open the inspiratory channel and the expiratory valve. The ventilator will shut down and an emergency buzzer providing an acoustic alarm and the blinking alarm LED on the device s front side.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.

Where it was distributed

US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

California Colorado Illinois Louisiana Minnesota New York Oklahoma Virginia Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Number: 3084, 3088

Where was it sold?

US distribution to CA, CO, IL, LA, MN, NY, OK, VA, WI. Worldwide distribution to China, Germany, India, Indonesia, Israel, Kazakhstan, Korea, Pakistan, Taiwan, Poland, Armenia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 80467

Reported	Class	Recall	Company	Reason	Where
22 Aug 2018	CLASS II	Hamilton-C1 Ventilator Unit recalled by Hamilton Medical AG	Hamilton Medical	Potency & Assay	9 states

More recalls from Hamilton Medical

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8 Jul 2026Device	CLASS II	IntelliCuff, Portable automatic cuff pressure controller recalled	Hamilton Medical	Packaging Defects	Nationwide
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27 Aug 2025Device	CLASS I	Hamilton C6 recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide
6 Aug 2025Device	CLASS I	Breathing circuit set, coaxial, 1.80 m, with flow sensor recalled	Hamilton Medical	Device Malfunction	Nationwide
26 Jun 2024Device	CLASS I	Ventilator Hamilton-C6, PN recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide

Other CPAP & Ventilators recalls

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30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled	CooperSurgical	Other	Nationwide
30 Sep 2026Device	CLASS I	Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled	CooperSurgical	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide