Stop using nowMedical device recall · FDA · Published December 13, 2019
Teleflex Recalls HUDSON RCI Comfort Flo Humidifier Kit Due to Water Flood Risk
Teleflex Medical recalls the HUDSON RCI Comfort Flo Humidification System (REF 2410) due to potential water flooding in the circuit during high-flow oxygen therapy.
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Teleflex Medical Inc. is recalling the HUDSON RCI Comfort Flo Humidification System, specifically the humidifier nebulizer kit with reference number 2410. The recall affects approximately 127,293 devices distributed nationwide. The issue involves a potential design flaw where water could flood the column and enter the patient circuit under specific pressure conditions. Read more at govinfonow.com/recall/66320-teleflex-hudson-rci-comfort-flo-humidifier-kit-water-flooding-risk.
“Teleflex Recalls HUDSON RCI Comfort Flo Humidifier Kit Due to Water Flood Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/66320-teleflex-hudson-rci-comfort-flo-humidifier-kit-water-flooding-risk. Based on FDA recall #Z-1114-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2020%22&limit=1).
The FDA announced on 2019-12-13 that Teleflex Medical is voluntarily recalling the HUDSON RCI Comfort Flo Humidification System due to a potential water flood hazard. The agency issued recall number Z-1114-2020 for the device.
According to the FDA, there is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Context
GovInfoNow's records show Teleflex Medical Inc has 11 other recalls on record since 2019-10-11. Other recent recalls of similar products include Medline Medical Procedure Kits Recalled (2025-12-16), Medline medical procedure kits with Strykeflow 2 irrigation leak risk - recall (2025-12-16), and Laborie Solar GI System Recall (2026-05-21).
How to tell if you have this one
Check if you have the HUDSON RCI Comfort Flo Humidification System, humidifier nebulizer kit with REF 2410. Verify the GTIN 14026704659347 and check the lot number on the device against the extensive list provided in the record (e.g., 74M1400306, 74A1801553, etc.).
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Cease use of the recalled HUDSON RCI Comfort Flo Humidification System due to the risk of water entering the circuit.
Contact Teleflex Medical for remedy details
The recall record does not specify a current remedy, return process, or replacement instructions; contact the manufacturer directly for further guidance.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Many lots are affected, including but not limited to: 74M1400306, 74A1801553, 74B1900011, and 74D1903025. You must check the specific lot number on your device against the full list in the record.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1114-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1114-2020 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.