Medline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
Medline is recalling 145,525 neonatal and infant heated wire breathing circuits due to potential thermal damage that could cause airway obstruction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of serious harm (airway obstruction, respiratory distress) but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 145,525 units of neonatal and infant heated wire breathing circuits. The affected products are labeled as various HUDSON RCI circuits, including specific Medline Product Numbers/SKUs such as HUD78007, HUD78009, 780-13, 780-14, 780-15, and HUD78018. The recall covers all lot numbers for these specific SKUs.
The recall is being issued because the heated wire connector (pigtail) at the humidifier may experience sporadic failure. This failure can result in discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Such device failure may predispose infants to bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, which can lead to elevated oxygen consumption and worsening respiratory distress.
The affected products were distributed worldwide, including nationwide in the United States and in Panama. Healthcare facilities and consumers should stop using these specific breathing circuits immediately and contact Medline Industries, LP for further instructions on return or replacement.
The recalled product
- Product
- Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU…
- Manufacturer
- Medline Industries, LP
- Affected units
- 145,525
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 1) Medline Product Number/SKU HUD78007
- UDI/DI 10197344042463 (each) 20197344042460 (case)
- All lot numbers
- 2) Medline Product Number/SKU HUD78009
- UDI/DI Discontinued (each) Discontinued (case)
- 3) Medline Product Number/SKU 780-13
- 4) Medline Product Number/SKU 780-14
- 5) Medline Product Number/SKU 780-15
- 6) Medline Product Number/SKU HUD78018
- UDI/DI 10197344010660 (each) 20197344010667 (case)
- All lot numbers.
Distribution
Distributed nationwide across the United States.
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