DeviceSignal · Recall classified
Medline Industries, LP
FDA classified a device recall on 2026-08-21 · Class II · Z-2991-2026
EventRecall classified
Effective2026-08-21
ClassificationClass II
On 2026-08-21 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU…. Recall Z-2991-2026. The firm initiated it on 2026-07-13. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2991-2026
- Classification
- Class II
- Classified on
- 2026-08-21
- Initiated on
- 2026-07-13
- Firm
- Medline Industries, LP
- Reason
- 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.
- Product
- Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2991-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
09322087d62a3fba6698c5de346461fa4f3dbfcb489ec237aab6123e56ef9a15- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)