HAMILTON C1 Ventilator
Medical device recall Z-2139-2023. Published in FDA’s Enforcement Report on Aug 2, 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 Aug 2, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 50 states named in where it went
- 689 systems 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?
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
689 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: HAMILTON-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318 6323 6586 7075 7078 7087 7283 7867 7869 7870 7874 7878 7887 7902 7923 7932 7935 8259 8277 8431 8444 8463 8749 8940 8943…
Every code shown here, 1,995 characters
Model: HAMILTON-C1 REF: 161001 1610010 UDI-DI Code: 07630002800747 Serial Numbers: 6006 6023 6024 6203 6264 6267 6318 6323 6586 7075 7078 7087 7283 7867 7869 7870 7874 7878 7887 7902 7923 7932 7935 8259 8277 8431 8444 8463 8749 8940 8943 8951 9216 9228 9334 9392 9405 9409 9463 9467 9508 9571 9577 9584 9591 9597 9622 9629 9634 9652 9653 9654 9656 9664 9685 9704 9726 9728 9742 9742 9988 9995 10187 10194 10236 10241 10259 10262 10273 10361 10365 10371 10376 10383 10843 11016 11425 11493 11495 11499 11504 11530 11533 11574 11576 11577 11578 11579 11656 11751 11976 11992 12002 12024 12029 12091 12297 12312 12319 12319 12338 12339 12340 12343 12344 12345 12347 12353 12354 12355 12360 12361 12362 12363 12364 12365 12371 12373 12374 12375 12377 12382 12383 12388 12390 12397 12408 12410 12412 12413 12414 12417 12419 12426 12429 12431 12432 12439 12439 12441 12467 12998 13010 13018 13025 13349 13375 13425 13427 13440 14267 14307 14307 14309 14323 14324 14325 14330 14331 14336 14338 14345 14360 14426 14471 14678 14679 14681 14682 14683 14685 14686 14688 14693 14695 14698 14699 14701 14759 14769 14773 14813 15203 15354 15462 15487 15513 15565 15567 15568 15571 15576 15597 15604 15605 15613 15617 15622 15624 15636 15647 15657 15658 15659 15663 15675 15677 15681 15683 15689 15691 15694 15695 15697 15699 15717 15932 15970 16060 16101 16164 16182 16226 16236 16392 16397 16613 16970 17084 17149 17194 17201 17202 17204 17207 17208 17211 17213 17214 17221 17222 17223 17225 17226 17229 17236 17237 17238 17239 17241 17251 17259 17272 17479 17480 17481 17483 17610 17678 17698 17707 17716 17721 17736 17742 17746 17749 17751 17753 17754 17759 17770 17776 17787 17788 17798 17801 17802 17809 17839 17844 17974 18003 18022 18029 18031 18042 18068 18072 18073 18074 18076 18077 18079 18083 18089 18090 18097 18098 18102 18103 18108 18193 18420 18479 18564 18641 18754 18759 18765 18768 18773 18784 18793 18796 18799 18801 18804 18806 18807 18810 18826 18828 18831 18832 18833 18835 18837 18840…
FDA’s list runs to 4,181 characters. The first part is shown; the rest is on FDA’s record.
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.
U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming Added 08/30/2023 - Puerto Rico O.U.S.: Bahamas, Japan and Mexico
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jun 15, 2023.
- FDA classified it on Jul 21, 2023.
- FDA’s Enforcement Report published it on Aug 2, 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.”
- FDA’s list of codes runs to 4,181 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.