HAMILTON C3 Ventilator
Medical device recall Z-2142-2023. 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
- 701 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 C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
701 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012 1014 1019 1028 1030 1032 1042 1123 1174 1187 1192 1198 1201 1202 1206 1207 1219 1220 1221 1224 1225 1229 1232 1233 1259…
Every code shown here, 1,998 characters
Model: HAMILTON-C3 REF 160005 UDI-DI Code: 07630002801881 Serial Numbers: 1001 1003 1004 1006 1008 1009 1010 1011 1012 1014 1019 1028 1030 1032 1042 1123 1174 1187 1192 1198 1201 1202 1206 1207 1219 1220 1221 1224 1225 1229 1232 1233 1259 1261 1264 1266 1458 1459 1461 1464 1465 1509 1510 1511 1512 1513 1514 1515 1516 1517 1528 1529 1530 1531 1534 1536 1584 1592 1597 1598 1623 1648 2004 2006 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2027 2040 2042 2044 2045 2046 2055 2064 2101 2112 2118 2119 2133 2139 2140 2171 2172 2173 2174 2175 2177 2253 2256 2257 2259 2260 2261 2262 2263 2265 2266 2285 2345 2346 2347 2360 2363 2364 2365 2367 2368 2416 2433 2481 2483 2483 2497 2499 2499 2550 2725 2733 2757 2953 3102 3104 3109 3110 3111 3112 3382 3385 3732 3786 3803 3930 4036 4037 4038 4042 4044 4057 4060 4068 4069 4070 4072 4075 4092 4092 4136 4137 4138 5307 5330 5353 5448 5509 5613 5775 5778 5781 5783 5785 5787 5788 5793 5794 5803 5812 5825 5833 5840 5845 5851 5853 5862 5876 5912 5918 5919 5920 5922 5926 5939 5940 5941 5942 5943 5944 5945 5946 5947 5977 5979 5980 5987 5988 5989 5990 5991 5992 5993 5994 5995 5996 5997 5998 5999 6000 6001 6011 6012 6013 6014 6015 6016 6017 6019 6021 6026 6027 6033 6034 6035 6036 6037 6038 6039 6041 6044 6055 6057 6823 6983 6991 7086 7100 7142 7175 7177 7178 7179 7180 7181 7182 7186 7187 7190 7192 7193 7194 7195 7196 7197 7198 7199 7204 7206 7208 7225 7234 7258 7283 7336 7539 7541 7543 7544 7545 7546 7554 7572 7573 7597 7603 7768 7797 7814 8168 8275 8276 8277 8320 8324 8385 8506 8686 8691 8692 8693 8750 8776 8831 8838 9320 9324 9335 9337 9340 9345 9346 9350 9361 9364 9394 9565 9627 9628 9680 9711 9818 9819 9821 9823 9828 9844 9855 9858 9862 9905 10009 10012 10014 10015 10031 10108 10110 10112 10117 10130 10181 10212 10260 10290 10711 10723 10726 10750 10755 10790 10880 10972 10984 11002 11023 11027 11038 11041 11092 11093 11147 11389 11394 11397 11403 11412 11414 11421 11427 11428 11432 11436 11561 11571…
FDA’s list runs to 3,782 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 3,782 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.