CooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box.
CooperSurgical recalls 4 model neonatal CPAP replacement sets with Stay-Flex tubing that may become loose, reducing CPAP pressure and oxygenation. Affected units have specific model numbers and lot codes.
Use caution until it’s fixed
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 happened, in plain English
CooperSurgical is recalling four specific models of neonatal CPAP replacement sets because the Stay-Flex tubing can become loose, potentially reducing oxygen delivery to infants. This could lead to decreased oxygenation if not fixed. Read more at govinfonow.com/recall/1292607-coopersurgical-neonatal-cpap-replacement-set-loose-tubing-may-reduce-oxygenation.
Source Summary by GovInfoNow · govinfonow.com/recall/1292607-coopersurgical-neonatal-cpap-replacement-set-loose-tubing-may-reduce-oxygenation · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3140-2026
Cite this page
“CooperSurgical Neonatal CPAP Replacement Set: Loose Tubing May Reduce Oxygenation.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292607-coopersurgical-neonatal-cpap-replacement-set-loose-tubing-may-reduce-oxygenation. Based on FDA recall #Z-3140-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3140-2026%22&limit=1).
Why it’s dangerous
The Stay-Flex tubing may become loose during assembly or use, causing a loss of CPAP pressure. This could reduce oxygen delivery to infants, potentially leading to decreased oxygenation if the connection isn't fixed.
Who’s affected
Parents or caregivers of newborns using neonatal CPAP therapy with the recalled sets are most at risk. The affected units are limited to specific model numbers and lot codes.
How to tell if you have this one
Check the model number on the packaging: 44-0712, 44-0707, 44-0709, or 44-0715. The affected units also have specific lot codes listed in the recall notice.
- Brand
CooperSurgical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3139-2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.; 1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722. 2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621. 3. Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760. 4. Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619. 5. Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763. | 2,643 boxes (13,215 units) |
| Z-3140-2026 | 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.; 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. | 149 boxes (745 units) |
What to do — step by step
Check Model Number
Identify the model number on the packaging to see if it matches 44-0712, 44-0707, 44-0709, or 44-0715.
Contact Manufacturer
Reach out to CooperSurgical for further assistance if you have the affected model numbers.
Questions people ask
How many units are affected?
Four specific model numbers with 5 units per box are affected.
What is the risk of using the recalled sets?
The tubing may become loose, reducing CPAP pressure and oxygen delivery to infants, potentially causing decreased oxygenation.
Do I need to stop using the recalled sets immediately?
No, but you should check the model number and contact CooperSurgical if you have the affected units.
Contact CooperSurgical
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-3140-2026 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-3140-2026 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3140-2026 (August 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3140-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.