Class II U.S. Food and Drug Administration

3B Medical, Inc. Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface recall: Packaging and labeling discrepancy involving product size identification

Recall published 3 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2740-2026
Published
July 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
3B Medical, Inc.
Product type
Medical devices
Units affected
375
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • RII1001

Model or item number

On the rating label, the box or the instruction sheet.

  • RII1001
  • RII1002
  • RII1003 Affected Lots RII1001

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

3B Medical, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: 3B Medical, Inc. — 5475 Rings Rd Ste 550, Dublin, OH, 43017-7537

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was 3B Medical, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code RII1001; model number RII1001, RII1002, RII1003 Affected Lots RII1001. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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