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Open, Classified

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

FDA Recall Z-2740-2026 · Posted 2026-07-15

Recalling Firm3B Medical, Inc.
Recall StatusOpen, Classified
Product CodeBZD
Date Initiated2023-06-15
Product Quantity375

Reason for Recall

Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1122713B WILLOW3B Products, LLC · 2012-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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