Search U.S. Product Recalls Database

Showing 5581–5600 of 11714 results

Sort:

TFNA Femoral Nail 11mm (Synthes) – Sterility Concerns (2024)

Products not sterilized, sterility cannot be confirmed

FDAJan 24, 2024Nationwide• Synthes (USA) Products LLC

ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Moderate

FDAJan 24, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Stay Informed

Search Product Recalls

TFNA Femoral Nail 11mm (Synthes) – Sterility Concerns (2024)

ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

RIA Tube Assembly (Synthes) – Sterilization Uncertainty (2024)

2.5mm Drill Bit (Synthes) – Sterilization Uncertainty (2024)

Titanium Hindfoot Nail (Synthes) – Sterilization Uncertainty (2024)

1.5MM Drill Bit (Synthes) – Sterility Concerns (2024)

Stay-Safe Luer Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

Stay-Safe Luer Lock Adapter (Fresenius) – Leachable Concerns (2024)

Stay-Safe Luer Catheter Extension (Fresenius) – Leachable Concerns (2024)

CVS Health Wound Tracking Dressing (Medline) – Failed Sterility Test (2024)

Norepinephrine Injection (Baxter) – Label Concentration Error (2024)

Stay-Safe Safe Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Duet External Drainage System (Medtronic) – Catheter Disconnection Risk (2024)

Epidural Tray (B. Braun) – Connector Compatibility Issue (2024)

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Homecare Series Bed (Invacare) – Weld Defect Potential (2024)

Tensive Conductive Adhesive Gel (Parker) – Viscosity Complaint (2024)

Battery Mobile X-ray Unit (Sedecal) – Anti-Fall System Interference (2024)

BiMobile Dual Mobility System (Waldemar Link) – Mislabeling Risk (2024)