RecallRadar
FDA · Medical devicesClass I

CooperSurgical, Inc. medical device recall: Inca

Lead

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
99643
Recall initiated
Aug 11, 2026
Classified by FDA
Sep 18, 2026
Posted in Enforcement Report
Sep 30, 2026
Recalling firm
CooperSurgical, Inc.
Firm location
Trumbull, CT, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

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.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Aug 11, 2026. FDA classified it 38 days later, on Sep 18, 2026. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru. CooperSurgical, Inc. has 58 recalls in our records.

Recalled products (2)

  • Z-3139-2026 Class I Ongoing

    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.

    Codes / lots: 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.

    Quantity: 2,643 boxes (13,215 units)

  • Z-3140-2026 Class I Ongoing

    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.

    Codes / lots: 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: 149 boxes (745 units)

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 99643
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.