Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Setsee related information
Date Initiated by FirmAugust 11, 2026
Date PostedSeptember 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3139-2026
Recall Event ID 99643
510(K)NumberK911780 
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
ProductINCA (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.
Code Information 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.
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactMatthew Kelleher
203-601-5200
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionCooperSurgical notified consignees on about 08/11/2026 via "URGENT Medical Device Recall" letter. Consignees were notified of the issue and potential hazard, and were instructed to identify affected units on hand, if any loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device, and remove all product of the subject lots from inventory and note the number of units to be returned on the attached Recall Response Form that is provided. Distributors were instructed to remove all product of the subject lots from inventory and note the number of units to be returned on the attached Distributor Only Acknowledgement Form. Additionally, they were instructed to communicate the recall notification to all customers that they distributed these devices to.
Quantity in Commerce2,643 boxes (13,215 units)
DistributionNationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BZD
-
-