RecallReported September 30, 2026
Class I recall by CooperSurgical, Inc.
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712,…
FDA's enforcement report of September 30, 2026 lists a Class I recall by CooperSurgical, Inc. of Trumbull, CT. Product: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712,…. Status: Ongoing.
On the record
- Recalling firm
- CooperSurgical, Inc.
- Location
- Trumbull, CT
- Classification
- Class I
- Status
- Ongoing
- Recall number
- Z-3140-2026
- Product type
- Devices
- Recall initiated
- 2026-08-11
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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