Z-2740-2026Class II

Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small)...

Name: Z-2740-2026 Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small)...
Creator: 3B Medical, Inc.
Published: 2023-06-15
License: https://open.fda.gov/license/

3B Medical Inc / initiated 2023-06-15 / Open, Classified / root cause: labeling and UDI

FDA source

3B Medical, Inc. began a recall of Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version... on 2023-06-15. FDA classified it as Class II and gives the reason as "Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2740-2026
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-15
Posted: 2026-07-15
Recalling firm: 3B Medical Inc
Product: Brand 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
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: This 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 commerce: 375
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2740-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2740-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-15

Product code BZD

K112271Class II3B Willow3B Products, LLC / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)