Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium
FDA device recall Z-2740-2026 · posted 2026-07-15 · Open, Classified
Recall details
- Recalling firm
- 3B Medical, Inc.
- Reason for recall
- Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
- Action taken
- 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
- Status
- Open, Classified
- Product code
- BZD
- Quantity affected
- 375
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-06-15
- Date posted
- 2026-07-15
- Location
- Dublin, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3B WILLOW (K112271) | 3B Products, LLC | 2012-02-16 |