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Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Moderate

FDAFeb 25, 2025Nationwide• Stryker Corporation

Metformin Extended-Release 500mg (A-S Medication) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules.

Class IIModerate

FDAFeb 25, 2025Nationwide• A-S Medication Solutions LLC

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Nasopore Nasal Dressing (Stryker) – Packaging Seal Issue (2025)

Metformin Extended-Release 500mg (A-S Medication) – Foreign Tablets (2025)

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

TruSystem 7500 Hybrid (Baxter) – Software Control Fault (2025)

TruSystem 7500 Hybrid (Baxter) – Software Control Fault (2025)

Otopore Ear Wound Dressing (Stryker) – Packaging Seal Issue (2025)

COR Disposable Kit (DePuy Mitek) – Missing Graft Loader Pin (2025)

COR Disposable Kit (DePuy Mitek) – Missing Pin (2025)

Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)

Medline Convenience Kits (Medline) – Tube Recall Issue (2025)

Tropicamide Ophthalmic Solution (Imprimis) – Sub-Potent Drug (2025)

Livalo 4mg (Kowa) – Foreign Tablets (2025)

Zapzyt Acne Treatment Gel (Denison) – Benzene Contamination (2025)

Boppli Bedside Device Kit (PYRAMES) – Noise Detection Issue (2025)

Chocolate Peanut Butter Protein Balls (Prep'd CDA) – undeclared ingredients (2025)

Medline Procedure Kits (Medline) – Cannula Concern (2025)

Ready Care Chocolate Shake Plus (Lyons Magnus) – Listeria Risk (2025)

Medline Procedure Kits (Medline) – Male Luer Material Issue (2025)

Hazelnut Coffee Creamer (Danone Wave) – spoilage risk (2025)

Ready Care Strawberry Banana Shake (Lyons Magnus) – listeria risk (2025)