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

Recall Z-0998-2025 — Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423330 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use i

U.S. FDA — Device Enforcement · United States · 2024-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0998-2025
Date of alert: 2024-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Olympus Corporation of the Americas
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04953170383519

Reported risk: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

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.

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