ProductGuru Recalls

Official recall record

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712,

US FDA — Medical Devices · 2026-08-11 · United StatesClass I
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2026-08-11
Country of alert
United States
Alert level
Class I
Alert type
recall
Barcode (EAN/GTIN)
60888937009516
Brand on record
CooperSurgical, Inc.
Product category
Medical Device

What the authority reported

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-22.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

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