CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled

Medline Industries is recalling Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo, Medline Product Number, distributed nationwide in the US. The recall was initiated on 13 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes
Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2991-2026
FDA event ID
99403
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
13 Jul 2026
FDA classified
21 Aug 2026
Reported
2 Sep 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Device Malfunction

Timeline

13 Jul 2026Recall initiated by company
21 Aug 2026Classified by FDA+39 days
2 Sep 2026Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Panama.

Nationwide

Questions about this recall

Why was it recalled?

Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.

Which lots are affected?

All lot codes

Where was it sold?

Worldwide distribution - US Nationwide and the country of Panama.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99403

This product is part of a recall event; the main page for the event is Medline breathing circuits labeled as: Hudson Rci, Circuit recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline breathing circuits labeled as: Hudson Rci, Circuit recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline breathing circuits labeled as: Medline Hudson Rci recalledMedline IndustriesDevice MalfunctionNationwide

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