HAMILTON T1 Ventilator
Medical device recall Z-2140-2023. 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
- 2319 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 T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
2319 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: HAMILTON-T1 REF: 161006 1610060 161009 1610090 UDI-DI Code: 07630002801850 07630002813532 07630002806091 07630002813549 Serial Numbers: 3057 3058 3063 3070 3077 3081 3085 3089 3093 3112 3115 3119 3121 3124 3126 3127 3129 3131 3132…
Every code shown here, 1,998 characters
Model: HAMILTON-T1 REF: 161006 1610060 161009 1610090 UDI-DI Code: 07630002801850 07630002813532 07630002806091 07630002813549 Serial Numbers: 3057 3058 3063 3070 3077 3081 3085 3089 3093 3112 3115 3119 3121 3124 3126 3127 3129 3131 3132 3133 3136 3138 3140 3168 3169 3185 3191 3193 3195 3199 3200 3235 3236 3241 3243 3245 3247 3249 3250 3258 3259 3263 3275 3280 3299 3307 3309 3311 3312 3313 3317 3320 3340 3574 3576 3577 3579 3580 3604 3605 3613 3616 3618 3621 3629 3657 3658 3661 3663 3666 3668 3672 3691 3702 3703 3716 3731 3731 3739 3744 3746 3747 3748 3749 3750 3751 3761 3785 3792 3803 3824 3829 3832 3840 3848 3852 3853 3854 3862 3869 3875 3886 3889 3890 3902 3921 3933 3937 3953 3960 3961 3971 3973 3974 3983 3986 3987 3989 3990 4017 4046 4050 4050 4052 4052 4053 4057 4066 4070 4075 4076 4086 4090 4093 4094 4096 4100 4102 4118 4121 4123 4244 4339 4341 4349 4354 4355 4416 4422 4429 4502 4516 4518 4524 4527 4534 4535 4551 4552 4583 4584 4592 4593 4595 4596 4599 4600 4629 4639 4696 4724 4726 4729 4730 4731 4775 4794 4915 4920 4928 4965 4968 4982 4992 4993 4996 5000 5001 5002 5007 5011 5034 5052 5057 5062 5063 5069 5074 5075 5113 5116 5120 5169 5181 5234 5238 5239 5246 5260 5261 5264 5267 5268 5271 5275 5277 5287 5288 5292 5293 5294 5296 5297 5300 5301 5302 5303 5305 5308 5311 5312 5314 5315 5319 5320 5323 5324 5326 5327 5328 5331 5332 5334 5335 5337 5339 5340 5341 5343 5397 5421 5427 5428 5430 5431 5435 5438 5439 5447 5450 5454 5460 5474 5481 5483 5484 5485 5486 5487 5488 5489 5490 5491 5492 5493 5494 5495 5496 5497 5499 5501 5504 5547 5552 5585 5669 5676 5678 5680 5688 5691 5692 5694 5695 5696 5697 5698 5699 5700 5701 5702 5703 5704 5705 5707 5708 5709 5713 5714 5716 5719 5720 5721 5722 5724 5727 5728 5736 5739 5742 5752 5756 5756 5760 5833 5834 5835 5882 5901 5961 5993 5994 5995 5996 5998 5999 6001 6015 6024 6025 6026 6028 6030 6031 6032 6034 6035 6036 6037 6047 6048 6051 6057 6058 6068 6069 6097 6098 6099 6101 6117 6120 6122 6123 6124 6125 6166 6170 6172 6188 6191…
FDA’s list runs to 13,829 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 13,829 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.