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Showing 1961–1980 of 68218 results

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Biofinity Toric Multifocal Lens (CooperVision) – Seal Defect (2025)

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

FDAJun 16, 2025Nationwide• CooperVision, Inc.

SafeStar 60A Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

SafeStar 55 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

Low

FDAJun 16, 2025Nationwide• Draeger, Inc.

BD PhaSeal Injector (Unknown) – Instructions Omission (2025)

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

FDAJun 16, 2025Nationwide

Biofinity XR Toric Contact Lens (CooperVision) – Seal Defect (2025)

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

FDAJun 16, 2025Nationwide• CooperVision, Inc.

HME TwinStar HEPA Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

Chocolate Nonpareils (Wegmans) – undeclared milk (2025)

Undeclared Milk

Undeclared milk

Class IIModerate

FDAJun 16, 2025DE, IN, MD +7 more• Mellace Family Brands California Inc

Nonpareil Chocolates (Weaver) – undeclared milk (2025)

Undeclared Allergen

undeclared milk allergen

FDAJun 16, 2025AZ, GA, LA +11 more• Weaver Nut Company, Inc

Testosterone Pellet (Qualgen) – Incorrect Label Printing (2025)

Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.

FDAJun 16, 2025Nationwide• Qualgen, LLC

Sodium Chloride Injection (B Braun) – Sterility Compromise (2025)

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

Class IIModerate

FDAJun 16, 2025Nationwide• B BRAUN MEDICAL INC

Lisdexamfetamine Capsules 60mg (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Class IIModerate

FDAJun 16, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Needle Mushrooms (LLK Trading) – bacterial contamination (2025)

Product tested positive for L. monocytogenes .

FDAJun 16, 2025NY• LLK TRADING INC

SafeStar 90 Plus Filter (Draeger) – CO2 Sampling Issue (2025)

Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

FDAJun 16, 2025Nationwide• Draeger, Inc.

InPen App (Medtronic) – Insulin Dosing Error (2025)

Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.

FDAJun 16, 2025GA• Medtronic MiniMed, Inc.

Nonpareil Chocolates (Weaver) – undeclared milk (2025)

Undeclared Allergen

Undeclared Milk Allergen

FDAJun 16, 2025AZ, GA, LA +11 more• Weaver Nut Company, Inc

Nonpareil Chocolates (Weaver) – undeclared milk (2025)

Undeclared Allergen

Undeclared Milk Allergen

FDAJun 16, 2025AZ, GA, LA +11 more• Weaver Nut Company, Inc

Nonpareils (Weaver) – undeclared milk (2025)

Undeclared Allergen

undeclared milk allergen

FDAJun 16, 2025AZ, GA, LA +11 more• Weaver Nut Company, Inc

Blueberry Mini Muffins (Wegmans) – metal contamination (2025)

Product may contain foreign objects of metal origin.

Class IIModerate

FDAJun 14, 2025DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Chocolate Chip Mini Muffins (Wegmans) – metal contamination (2025)

Product may contain foreign objects of metal origin.

Class IIModerate

FDAJun 14, 2025DE, MD, MA +6 more• Wegmans Food Markets, Inc.

Mini Muffins French Toast (Wegmans) – metal contamination (2025)

Product may contain foreign objects of metal origin.

Class IIModerate

FDAJun 14, 2025DE, MD, MA +6 more• Wegmans Food Markets, Inc.

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