Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
Medical device recall Z-2525-2023. Published in FDA’s Enforcement Report on Sep 27, 2023.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 27, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 164 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
164 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,047 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distribution US nationwide, including Puerto Rico. OUS: Not provided
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 26, 2023.
- FDA classified it on Sep 20, 2023.
- FDA’s Enforcement Report published it on Sep 27, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hamilton Medical, Inc., of Reno, NV.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.