Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0314-2025 — 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.

U.S. FDA — Device Enforcement · United States · 2022-04-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0314-2025
Date of alert: 2022-04-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Nihon Kohden America Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 14931921904043

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0314-2025 — 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.

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