CLASS I ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recalled
Hamilton Medical is recalling Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator, distributed nationwide in the US. The recall was initiated on 26 Jul 2023 and the FDA has classified it as Class I.
Check your package
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-2525-2023
- FDA event ID
- 92873
- Recalling firm
- Hamilton Medical, Reno, NV
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Jul 2023
- FDA classified
- 20 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- CPAP & Ventilators
Timeline
| 26 Jul 2023 | Recall initiated by company | |
| 20 Sep 2023 | Classified by FDA | +56 days |
| 27 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Where it was distributed
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Questions about this recall
Is Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recalled?
Yes. Hamilton Medical recalled Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator on 26 Jul 2023. The recall is Class I and its status is Ongoing. Recall number Z-2525-2023.
Why was it recalled?
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Which lots are affected?
UDI: 07630002800747 & 07630002813426 / Affected Serial Numbers: 24177 24196 24216 24217 24219 24247 24250 24324 24360 24370 24431 24460 24467 24480 24487 24511 24523 24552 24556 24557 24558 24561 24564 24565 24571 24572 24574 24578 24583 24587 24591 24595 24612 24616 24620 24622 24651 24662 24672 24691 24965 24991 25006 25010 25011 25014 25022 25096 25109 25111 25118 25141 25142 25151 25152 25158 25163 25169 25171 25178 25183 25184 25185 25187 25189 25231 25232 25370 25433 25437 25456 25511 25516 25534 25538 25559 25576 25578 25612 25628 25632 25636 25678 25690 25712 25716 25721 25745 25747 25750 25753 25756 25757 25758 25759 25760 25761 25762 25763 25764 25769 25771 25777 25782 25784 25794 25809 25817 25822 25823 25830 25832 25834 25835 25841 25851 25852 25853 25862 25888 25893 25907 25913 25919 25924 25938 26007 26011 26042 26052 26063 26064 26069 26071 26081 26087 26201 26363 26390 26502 26510 26516 26639 26640 26641 26652 26660 26725 26731 26732 26733 26803 26857 26859 26870 26893 26896 26944 26977 27201 27504 27571 29013 31746
Where was it sold?
Distribution US nationwide, including Puerto Rico. OUS: Not provided
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hamilton Medical
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-MR1, REF: 161010, Intensive Care Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton C1/T1/MR1 recalled by Hamilton Medical | Hamilton Medical | Lead & Heavy Metals | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |