Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1
Summary
The FDA issued a Class I for Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HA by Hamilton Medical AG. Reason: Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, .
Details
Source
Device Recall
External ID
Z-2463-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Lot/Code Info: REF/UDI-DI: 260127/07630002802956, 17630002802953; 260128/07630002802963, 17630002802960; 260167/07630002802970, 17630002802977; 260168/07630002802987, 17630002802984. Lot numbers between 200379 and 205050 (including both.)
Quantity Affected: 27,270 pcs
Reason for Recall
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Distribution
US Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR, OH, PA, CA, CO, ID, AZ, ME, MO, MI, IL, OR, VA, FL, NJ, SD, NY, NM, TN, CT, NE, OK, AL, GA, KY, NH, WY, ND, IN, UT, WV, DE, IA, PR, MN, LA, AK, HI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-29
Company
Domat/Ems, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
Hamilton Medical AG has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2463-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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