Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended Recalled by Nihon Kohden America Inc Due to Due to products being shipped/distributed to customers after...

Date: April 29, 2022
Company: Nihon Kohden America Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nihon Kohden America Inc directly.

Affected Products

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.

Quantity: 17 devices

Why Was This Recalled?

Due to products being shipped/distributed to customers after the products expiration date had past.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nihon Kohden America Inc

Nihon Kohden America Inc has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report