Hamilton G5 with software version between v2.41, v2.42, v2.50
Medical device recall Z-1624-2016. Published in FDA’s Enforcement Report on May 18, 2016.
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 May 18, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 1115 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as expected.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
1115, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 1278 1639 1686 1689 1691 1692 1695 1697 1699 1864 1984 2412 2413 2414 2417 2465 2505 2506 2521 2522 2523 2524 2525 2526 2527 2530 2531 2532 2591 2592 2593 2594 2595 2776 2780 2876 2877 2878 2880 2881 2882 2883 2884 2885…
Every code shown here, 1,996 characters
Serial numbers: 1278 1639 1686 1689 1691 1692 1695 1697 1699 1864 1984 2412 2413 2414 2417 2465 2505 2506 2521 2522 2523 2524 2525 2526 2527 2530 2531 2532 2591 2592 2593 2594 2595 2776 2780 2876 2877 2878 2880 2881 2882 2883 2884 2885 2886 2890 2894 3365 3366 3368 3370 3377 3611 3881 3882 3884 3885 3886 3887 3888 3889 3890 3914 4041 4044 4047 4057 4073 4074 4075 4077 4079 4080 4081 4088 4090 4091 4092 4093 4094 4095 4096 4097 4098 4099 4100 4101 4103 4104 4106 4108 4109 4110 4111 4112 4113 4115 4117 4118 4141 4144 4144 4145 4146 4147 4148 4149 4150 4223 4224 4226 4227 4345 4348 4351 4353 4354 4356 4357 4358 4359 4360 4365 4366 4598 4607 4625 4666 4671 4774 4779 4780 4781 4782 4783 4794 4904 4939 4946 4952 4956 5025 5026 5027 5028 5029 5030 5032 5038 5039 5040 5044 5045 5046 5047 5048 5050 5051 5052 5053 5054 5056 5057 5058 5061 5063 5064 5065 5080 5217 5248 5251 5252 5254 5256 5312 5357 5361 5362 5363 5374 5390 5395 5397 5437 5452 5457 5462 5465 5466 5468 5481 5523 5764 5774 5791 5794 5803 5815 5816 5818 5820 5825 5826 5827 5828 5829 5830 5831 5832 5834 5835 5836 5839 5842 5843 5888 5915 5930 5932 5933 5941 5948 6029 6031 6039 6062 6066 6072 6074 6075 6077 6078 6079 6080 6082 6083 6144 6211 6241 6247 6251 6261 6265 6276 6277 6278 6279 6291 6292 6293 6300 6303 6305 6306 6307 6309 6312 6315 6337 6377 6409 6411 6419 6422 6423 6432 6434 6438 6440 6441 6445 6451 6454 6470 6494 6495 6498 6499 6503 6504 6507 6508 6509 6511 6512 6515 6520 6556 6561 6614 6621 6625 6644 6647 6650 6653 6655 6656 6657 6658 6659 6661 6664 6669 6710 6740 6761 6763 6791 6795 6806 6832 6833 6835 6837 6838 6841 6856 6859 6890 6985 6986 6991 6992 6995 6999 7001 7021 7022 7030 7061 7077 7100 7329 7330 7336 7458 7526 7527 7528 7529 7530 7531 7532 7533 7534 7535 7536 7537 7538 7539 7558 7560 7566 7570 7585 7596 7597 7599 7605 7606 7646 7657 7658 7679 7684 7685 7919 7948 7984 8376 8390 8511 8512 8513 8535 8589 8610 8611 8617 8635 8637 8639 8643 8781 8783 8784 8785 8786 8791 8802 8803 8810 8816 8821…
FDA’s list runs to 6,006 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.
US distribution only.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Mar 9, 2016.
- FDA classified it on May 9, 2016.
- FDA’s Enforcement Report published it on May 18, 2016.
- FDA terminated it on Jun 29, 2017.
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 6,006 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.