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

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

Low

FDAFeb 13, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Remel Blood 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.

High

FDAFeb 13, 2025Nationwide• Remel, Inc

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

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

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

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

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

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

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

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

Proxima Drape (Medline) – sterility breach (2025)

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

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

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

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

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

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

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

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

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

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

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