INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Mod
Summary
The FDA issued a Class I for INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Fle by CooperSurgical, Inc.. Reason: 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 o.
Details
Source
Device Recall
External ID
Z-3140-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.
Lot/Code Info: 1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624. 2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057. 3. Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623. 4. Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625.
Quantity Affected: 149 boxes (745 units)
Reason for Recall
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.
Distribution
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-11
Company
Trumbull, CT
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
CooperSurgical, Inc. has 39 FDA actions in our database, including 36 recalls and 3 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperSurgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperSurgical, Inc. have FDA actions?
CooperSurgical, Inc. has 39 FDA actions in our database, including 36 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3140-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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