Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
Medical device recall Z-2527-2023. 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
- 1216 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-T1, REF: 161009, Intensive Care and Transport Ventilator
1216 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 07630002806091 & 07630002813549 / Affected Serial Numbers: 500816 501879 502181 502200 502587 502588 502589 502591 502647 502649 502650 502651 502687 502688 502690 502691 502696 502698 502699 502702 502704 502706 502709 502710 502711…
Every code shown here, 1,996 characters
UDI: 07630002806091 & 07630002813549 / Affected Serial Numbers: 500816 501879 502181 502200 502587 502588 502589 502591 502647 502649 502650 502651 502687 502688 502690 502691 502696 502698 502699 502702 502704 502706 502709 502710 502711 502712 502714 502715 502718 502722 502723 502724 502725 502726 502727 502728 502730 502731 502732 502733 502734 502735 502736 502737 502738 502739 502740 502741 502742 502744 502745 502746 502747 502749 502750 502753 502757 502760 502761 502763 502764 502765 502766 502767 502770 502771 502772 502775 502776 502781 502782 502784 502789 502791 502792 502794 502795 502797 502799 502801 502802 502803 502804 502805 502807 502808 502809 502811 502812 502814 502815 502816 502817 502818 502820 502821 502824 502832 502835 502842 502843 502844 502846 502847 502850 502851 502852 502853 502854 502855 502856 502858 502859 502860 502861 502862 502863 502864 502865 502867 502868 502869 502870 502872 502873 502875 502877 502879 502880 502881 502882 502883 502884 502885 502886 502887 502888 502889 502890 502891 502892 502893 502894 502895 502896 502897 502900 502901 502902 502903 502904 502905 502906 502907 502908 502909 502911 502912 502913 502914 502915 502916 502917 502918 502920 502921 502923 502924 502925 502926 502927 502929 502930 502931 502932 502933 502934 502935 502936 502937 502938 502939 502940 502941 502942 502943 502944 502945 502946 502947 502948 502949 502950 502951 502953 502954 502955 502956 502957 502958 502959 502960 502962 502963 502964 502965 502966 502967 502968 502970 502972 502973 502974 502975 502976 502977 502978 502979 502980 502988 502989 502990 502991 502992 502993 502994 502995 502996 502997 502998 502999 503000 503001 503002 503003 503004 503005 503006 503007 503008 503010 503016 503017 503020 503024 503033 503035 503052 503054 503058 503070 503073 503075 503076 503080 503088 503089 503092 503093 503094 503095 503096 503102 503103 503104 503105 503109 503114 503115 503116 503117 503118 503125 503126 503127 503128…
FDA’s list runs to 8,575 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.
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.”
- FDA’s list of codes runs to 8,575 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
-
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.