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NanoSight NS300 (Malvern) – Laser Safety Non-Compliance (2022)

Product found to not comply to Class 1 Laser safety requirement.

FDAApr 7, 2022Nationwide• MALVERN PANALYTICAL LTD Grovewood Road Malvern United Kingdom

Radial Head Replacement (Synthes) – Contraindication Update (2022)

DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.

FDAApr 7, 2022Nationwide• Synthes (USA) Products LLC

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NanoSight NS300 (Malvern) – Laser Safety Non-Compliance (2022)

Radial Head Replacement (Synthes) – Contraindication Update (2022)

Tray Ring Cover (Johnson & Johnson) – Sterility Breach (2022)

Accula SARS-CoV-2 Test (Mesa Biotech) – False Positive Risk (2022)

V8 Immunodisplacement Kit (Helena) – Microbial Growth (2022)

Mango Sorbet (Elegant Foods) – undeclared milk (2022)

Mandarin Orange Sorbet (Elegant Foods) – undeclared milk (2022)

Cherry Sorbet (Elegant Foods) – undeclared milk (2022)

Strawberry Sorbet (Elegant Foods) – undeclared milk (2022)

Lemon Sorbet (Elegant Foods) – undeclared milk (2022)

Chocolate Sorbet (Elegant Foods) – undeclared milk (2022)

Raspberry Sorbet (Elegant Foods) – undeclared milk (2022)

Blackberry Sorbet (Elegant Foods) – undeclared milk (2022)

Blood Orange Sorbet (Elegant Foods) – undeclared milk (2022)

Blueberry Sorbet (Elegant Foods) – undeclared milk (2022)

Medi-First XS Kit (Certified Safety) – Component Deviation (2022)

Verigene Processor SP (Luminex) – Temperature Limit Issue (2022)

SARS-CoV-2 Antigen Test (USA Medical) – Unauthorized Distribution (2022)

11272VN Flexible Video Urethro Cystoscope (Karl Storz) – disinfection failure (2022)

Karl Storz HD Cysto-Urethroscope (Karl Storz) – Disinfection Failure (2022)