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Showing 2801–2820 of 11714 results

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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.

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 Drape (Medline) – sterility breach (2025)

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

Low

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 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.

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.

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Nelarabine Injection (Zydus) – Impurity Specifications (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class IIModerate

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Mineral Sunscreen (Babyganics) – Chemical Contamination (2025)

Chemical Contamination

Class IIModerate

FDAFeb 13, 2025Nationwide• Johnson, S C and Son, Inc

Iodo Blanco Antiseptic (World Perfumes) – Container Defect (2025)

Defective Container: broken or leaking bottles.

Class IIModerate

FDAFeb 13, 2025FL• World Perfumes 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

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

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.

Alcohol Prep Pads (ViaMed) – Sterility Concerns (2025)

Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

Class IIModerate

FDAFeb 12, 2025FL• Wuxi Medical lnstrument Factory Co., Ltd.

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