Class 2 Device Recall Curaplex

• Date Initiated by Firm: June 12, 2026
• Date Posted: October 09, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0144-2027
• Recall Event ID: 99838
• Product Classification: Support, patient position - Product Code CCX
• Product: Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT
• Code Information: Lot ASM0043314 UDI-DI 00810094576127
• FEI Number: 3014680755
• Recalling Firm/ Manufacturer: Sarnova HC, Llc; 5000 Tuttle Crossing Blvd; Dublin OH 43016-1534
• For Additional Information Contact: BTM Customer Care; 800-533-0523
• Manufacturer Reason for Recall: Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Firm began notifying customers on June 12, 2026. Customers were instructed to inspect their kits from the affected lot to determine whether they contained the adult-sized cannula. If they found that the kit instead contained the pediatric cannula, customers were to discard the cannula and report it to the recalling firm. Bound Tree would then provide replacement adult nasal cannulas to the customer.
• Quantity in Commerce: 2,500 kits
• Distribution: US Nationwide distribution in the states of IA, IL, IN, KY, MI, MN, MO, ND, OH, UT.
• Total Product Life Cycle: TPLC 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.