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Showing 1561–1580 of 1734 results

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Proxima Drape (Medline) – sterility breach (2025)

Potential breach in pouch packaging which could lead to loss of sterility.

FDAFeb 13, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

ProPort Plastic Venous System (Smiths Medical) – port housing separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

Remel EMB Agar Plate (Remel) – Listeria Contamination (2025)

Listeria

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

FDAFeb 13, 2025Nationwide• Remel, Inc

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Potential breach in pouch packaging which could lead to loss of sterility.

FDAFeb 13, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Potential breach in pouch packaging which could lead to loss of sterility.

FDAFeb 13, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Potential breach in pouch packaging which could lead to loss of sterility.

FDAFeb 13, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Powerheart G5 AED (ZOLL) – device self-test failure (2025)

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).

FDAFeb 13, 2025Nationwide• ZOLL Medical Corporation

ProPort Venous Access System (Smiths Medical) – Port Housing Separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

Remel Blood Agar Plate (Remel) – Listeria Contamination (2025)

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

FDAFeb 13, 2025Nationwide• Remel, Inc

Portex Endotracheal Tube (Smiths Medical) – Diameter Inconsistency (2025)

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

Namic Convenience Kits (Medline) – luer fitting excess material (2025)

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

FDAFeb 12, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

BD BBL TB Stain Kit (Becton Dickinson) – expiration mismatch (2025)

One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

FDAFeb 12, 2025AZ, CA, CO +11 more• Becton Dickinson & Co.

Z1 Femoral Hip System (Zimmer) – stem inserter fracture (2025)

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

FDAFeb 12, 2025Nationwide• Zimmer, Inc.

Zebra Thermal Printer (Remel) – fire hazard (2025)

Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

FDAFeb 12, 2025AL, AZ, CA +14 more• Remel, Inc

Synapse PACS Software (Fujifilm) – patient age calculation (2025)

The incorrect computed patient age is showing in VX for patients less than 3 months old.

FDAFeb 11, 2025AZ, AR, CA +27 more• FUJIFILM Healthcare Americas Corporation

Medline C Section Pack (Medline) – syringe quality alert (2025)

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

FDAFeb 11, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Origin Data Management Software (Brainlab) – patient record merge (2025)

Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

FDAFeb 10, 2025Nationwide• Brainlab AG Olof-Palme-Str. 9 Munich Germany

Alcon Custom Pak (Alcon) – latex component labeling (2025)

Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product. If users or patients with latex sensitivity come into contact with latex, an allergic reaction may occur.

FDAFeb 10, 2025Nationwide• Alcon Research LLC

Candida ID Antigen (Immuno-Mycologics) – reduced sensitivity (2025)

Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.

FDAFeb 10, 2025Nationwide• Immuno-Mycologics, Inc

CardiFocus Heartlight X3 (CardioFocus) – sterile barrier (2025)

Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility.

FDAFeb 7, 2025Nationwide• CardioFocus, Inc.

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