Medline & Teleflex Neonatal Heated Breathing Circuits Recall for Fire Risk

On August 31 2023, Medline Industries, LP announced an urgent nationwide recall of Hudson RCI neonatal/infant heated-wire breathing circuits. Internal reports showed that the circuits’ electrical connector can overheat and smoke, creating a potential burn or fire hazard and jeopardising humidification delivered to fragile newborns. Hospitals, NICUs and caregivers should stop using the affected circuits immediately and follow the steps below to obtain credit from Medline.

Fire Hazard Details: Why the Hudson RCI Circuits Were Pulled

• The plastic “pigtail” connector that links the circuit to a Neptune humidifier may discolor, melt or emit smoke.
• If heating fails, infants may receive cold, dry respiratory gas, increasing the risk of bronchospasm, airway blockage, condensation (“rain-out”) and acute respiratory distress.
• Medline has documented an occurrence rate of just 0.011 %, yet the potential severity prompted a proactive recall.

Recalled Product Scope

All Hudson RCI neonatal/infant heated-wire breathing circuits manufactured on or before July 8 2023 and distributed between June 28 2021 – July 31 2023 are included.

Affected Item Numbers

• Medline-branded labels: HUD78001KIT, HUD78007, HUD78007KIT, HUD78008KIT, HUD78009, HUD78009KIT, HUD78013, HUD78014, HUD78015, HUD78017KIT, HUD78018, HUD78018KIT, HUD78019, HUD88001KIT, HUD88013KIT, HUD88014KIT, HUD88015KIT, HUD88017KIT
• Teleflex-branded labels: 780-01KIT, 780-07, 780-07KIT, 780-08KIT, 780-09, 780-09KIT, 780-13, 780-14, 780-15, 780-17KIT, 780-18, 780-18KIT, 780-19, 880-01KIT, 880-13KIT, 880-14KIT, 880-15KIT, 880-17KIT

Units manufactured on or after July 9 2023 are outside the recall and may remain in service.

Required Actions for Healthcare Facilities

1. Audit inventory for the above item numbers and manufacturing dates.
2. Quarantine and discard all recalled circuits—do not return them to Medline.
3. Alert respiratory therapists, NICU staff and biomedical engineers about the safety notice.
4. Request credit or ask questions via Medline Recall Support: 866-359-1704 (Mon–Fri, 8 a.m.–5 p.m. CST) or recalls@medline.com.
5. Report adverse events through the FDA’s MedWatch portal or by mail/fax (links below).

Sources

• Official FDA Recall Announcement

Report an Incident or Seek Care

If a patient experiences unexpected respiratory symptoms while using a Hudson RCI heated-wire breathing circuit, seek immediate medical evaluation. Adverse events can be reported to the FDA in two ways:

• MedWatch Online Voluntary Reporting Form
• Download FDA Form 3500 at fda.gov/MedWatch/getforms.htm and submit via mail or fax (1-800-FDA-0178).

Recall Images

FAQs — Medline & Teleflex Neonatal Heated Breathing Circuits Recall

1. What prompted the Medline & Teleflex heated breathing circuit recall?

Field complaints showed the heated-wire connector could overheat, melt or smoke, posing both fire and humidification failure hazards for neonatal patients.

2. Are Teleflex-labelled Hudson RCI circuits definitely included?

Yes. Teleflex-branded item numbers listed above—manufactured before July 9 2023—are fully covered by the same recall.

3. How do I confirm a Hudson RCI circuit is recalled?

Match both the item number and a manufacturing date on or before July 8 2023. Anything newer is not included.

4. Should recalled circuits be sent back to Medline?

No. Discard them on-site. Medline will issue credit once you confirm disposal following the recall notice instructions.

5. Have any injuries been linked to the Hudson RCI connector defect?

As of the FDA announcement, Medline reported no serious injuries; the action is precautionary to eliminate future risk.

6. Can I keep using circuits dated after July 9 2023?

Yes. According to Medline, units manufactured on or after that date incorporate design and process updates and may remain in service.