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U.S. Department of Health and Human Services

Class 2 Device Recall Rio II Nasal Pillows Interface

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 Class 2 Device Recall Rio II Nasal Pillows Interfacesee related information
Date Initiated by FirmJune 15, 2023
Date PostedJuly 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2740-2026
Recall Event ID 99247
510(K)NumberK112271 
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
ProductBrand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No
Code Information Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191
FEI Number 3009096682
Recalling Firm/
Manufacturer		 3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7537
For Additional Information Contact
863-226-6285
Manufacturer Reason
for Recall		Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
FDA Determined
Cause 2		Labeling Change Control
ActionThis is a retroactively reported action. On June 22, 2023, the firm notified affected customers via letter titled "Urgent Medical Device Recall." Customers were informed of the incorrect labeling. Customers were asked to examine their inventory to determine if they had any of the affected products on-hand. Customers were to discontinue distribution of identified products and to destroy any affected products on hand. Firm offered to issue credit memo. If product was further distributed, customers were asked to notify patients/downstream accounts and have the product returned for disposal.
Quantity in Commerce375
DistributionUS Nationwide distribution.
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
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