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PiezoWave 2 Control Unit (Richard Wolf) – Capacitor Failure (2025)

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

High

FDAApr 9, 2025GA• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany

Kapsin Ointment (Apipharma) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAApr 9, 2025AZ• Apipharma

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PiezoWave 2 Control Unit (Richard Wolf) – Capacitor Failure (2025)

Kapsin Ointment (Apipharma) – CGMP Deviations (2025)

Hemopropin Ointment (Apipharma) – CGMP Deviations (2025)

REMISOL Advance Software (Beckman Coulter) – Date Processing (2025)

Trailstar Topper (Trailstar) – Winch Strap Risk (2025)

ILJIN Hysolus CNG Tank (ILJIN) – Tank Assembly (2025)

Harley-Davidson Ohlins Forks (Harley-Davidson) – Fairing Issue (2025)

Volvo VNL (Volvo) – Interior Lighting (2025)

Artix MT Thrombectomy Device (Inari) – Vessel Range (2025)

Micro Bird G5 Transit Bus (Micro Bird) – Suspension Bolt (2025)

Porsche Macan Electric (Porsche) – Rearview Camera (2025)

Micro Bird G5 School Bus (Micro Bird) – Suspension Bolt (2025)

Ambu aScope 5 Broncho (Ambu) – Incorrect Labeling (2025)

Welch Allyn Life2000 Compressor (Baxter Healthcare) – Cybersecurity Vulnerability (2025)

Microstream Advance CO2 Filter (Philips) – Adapter Disconnection Risk (2025)

Bio 1 Granules (Science & Bio Materials) – Insufficient Product Volume (2025)

Nova Bus LFS (Nova Bus) – Wiring Harness (2025)

Welch Allyn Life2000 Ventilation System (Baxter Healthcare) – Cybersecurity Vulnerability (2025)

WCM Series Molding Equipment (Apic Yamada) – FDA Compliance Issue (2025)

Texas Olive Capers (All American Trading) – contamination risk (2025)