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Showing 2621–2640 of 3039 results

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Pacific Hemostasis Thromboplastin-D (Fisher Diagnostics) – Incorrect ISI Label (2025)

The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.

FDAMar 6, 2025PA• Fisher Diagnostics

Venue Go Models R2/R3 (GE Medical Systems) – Battery Fire Risk (2025)

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

FDAMar 6, 2025Nationwide• GE Medical Systems, LLC

Fentanyl Citrate (QuVa Pharma) – Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 6, 2025Nationwide• QuVa Pharma, Inc.

Prasugrel Tablets (Golden State Medical) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAMar 5, 2025Nationwide• Golden State Medical Supply Inc.

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

HoloBlueprint Application (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

ReNewal Coblator II Plasma Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

ReNewal ENT Coblator II PROcise Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

HiResolution Bionic Ear Battery Charger (Advanced Bionics) – Incorrect Packaging (2025)

Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

FDAMar 5, 2025AZ, FL, MI +3 more• Advanced Bionics, LLC

ReNewal Coblator II ENT Evac Wand (Medline) – Drip Chamber Disconnection (2025)

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

FDAMar 5, 2025Nationwide• MEDLINE INDUSTRIES, LP Northfield

Blueprint Mixed Reality (Stryker) – Guidance Instrumentation Difficulties (2025)

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

FDAMar 5, 2025AK, ID, MA +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Duloxetine Capsules (Rising Pharma) – Nitrosamine Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDAMar 5, 2025Nationwide• Rising Pharma Holding, Inc.

Testosterone Gel (Strides Pharma) – Benzene Presence (2025)

Presence of foreign substance: Presence of Benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• Strides Pharma, Inc.

Effaclar Duo (L'Oreal) – Benzene Contamination (2025)

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Golden Crop Candy (Blooming Import) – undeclared colors (2025)

Undeclared Allergen

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

Class IIModerate

FDAMar 5, 2025DE, MD, MA +5 more• Blooming Import Inc.

Effaclar Dermatological System (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

Effaclar Duo (L'Oreal) – Benzene Levels (2025)

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

Class IIModerate

FDAMar 5, 2025Nationwide• L'Oreal USA

AutoPulse NXT Resuscitation System (ZOLL) – Compression Malfunction (2025)

AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.

FDAMar 4, 2025AL, CA, CT +16 more• ZOLL Circulation, Inc.

Smart Control Vascular Stent System (Cordis) – Product Mix-Up (2025)

product mix-up; Vascular stent labeled as one size but contains a different size.

FDAMar 4, 2025AZ, AR, FL +2 more• Cordis US Corp

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