Fresh Recalls

FDAClass II · Medical device · Recall Z-2991-2026 · Recalled September 2, 2026

Medline Hudson RCI recall — Medline Industries, LP

Agency report date: September 2, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Medline Hudson RCI
Company / brand
Medline Industries
Lot / serial / date codes
All lot codes
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Medline Hudson RCI recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2991-2026
Brand
All Medline Industries recalls
Classification
Class II
Units affected
20 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Northfield, IL, United States
Firm address
3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots
All lot codes
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Firm notified the public via
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID
99403
Recall initiated
July 13, 2026
FDA classified
August 21, 2026
FDA report date
September 2, 2026

More Medline Industries recalls

Other medical device recalls from around the same time

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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