# FDA recall Z-0314-2025

> **Nihon Kohden America Inc** · Class II · device recall initiated 2022-04-29.

## Product

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.

## Reason for recall

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

## Distribution

U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.

## Key facts

- **Recall number:** Z-0314-2025
- **Recalling firm:** Nihon Kohden America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-29
- **Report date:** 2024-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2025

## Citation

> AI Analytics. FDA recall Z-0314-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0314-2025. Source: US FDA. Licensed CC0.

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