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Showing 1821–1840 of 4952 results

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CorNeat EverPatch (CorNeat Vision) – Surgical Patch Exposure (2025)

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

FDAAug 18, 2025Nationwide• CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel

ICEfx Maintenance Kit (Boston Scientific) – Desiccant Tube Issue (2025)

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

FDAAug 18, 2025Nationwide• Boston Scientific Corporation

ICEfx Cryoablation System (Boston Scientific) – Desiccant Tube Problem (2025)

Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

Low

FDAAug 18, 2025Nationwide• Boston Scientific Corporation

Ram 4500 (Ram) – Instrument Panel Problem (2025)

Chrysler (FCA US, LLC) is recalling certain 2026 Ram 3500, 3500 Cab Chassis, 2500, 4500 Cab Chassis, and 5500 Cab Chassis vehicles. The instrument panel may display an incorrect brake system warning light. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, "Control and Displays."

NHTSAAug 18, 2025Nationwide• RAM

Aesculap Elan 4 Duraguard (Aesculap) – Mislabeling Issue (2025)

Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

FDAAug 18, 2025MO• Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany

Chlorpromazine Hydrochloride 50mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Sodium Chloride Injection (B Braun Medical) - Particulate Matter (2025)

Presence of Particulate Matter.

FDAAug 18, 2025Nationwide• B BRAUN MEDICAL INC

Sulfamethoxazole Trimethoprim (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 25mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

EverPatch+ (CorNeat Vision) – Surgical Patch Exposure (2025)

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

FDAAug 18, 2025Nationwide• CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel

Chlorpromazine Hydrochloride 100mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 200mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Lactated Ringer's Injection (B Braun Medical) - Particulate Matter (2025)

Presence of Particulate Matter

FDAAug 18, 2025Nationwide• B BRAUN MEDICAL INC

Cleantail Breaded Butterfly Shrimp (Tampa Maid) – cesium contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 16, 2025FL, IL, KY +10 more• TAMPA MAID FOODS, LLC

Panko Breaded Butterfly Shrimp (Tampa Maid) – cesium contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 16, 2025FL, IL, KY +10 more• TAMPA MAID FOODS, LLC

Coconut Breaded Butterfly Shrimp (Tampa Maid) – cesium contamination (2025)

Product may be contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 16, 2025FL, IL, KY +10 more• TAMPA MAID FOODS, LLC

BeneVision N1 Patient Monitor (Mindray) – Alarm Pause Risk (2025)

Potential for activation of an abnormal alarm pause.

FDAAug 15, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

Peanut Rounds (Anderson Candy) – undeclared soy (2025)

Undeclared Allergen

Undeclared soy allergen

Class IIModerate

FDAAug 15, 2025AL, AZ, AR +7 more• Anderson Candy Company, LLC

Organic Mango Powder (New Acai Amazonas) – salmonella risk (2025)

Potential Salmonella contamination

FDAAug 15, 2025IA• NEW ACAI AMAZONAS LLC

Exactech Equinoxe Shoulder Liners (Exactech) – Dimensional Specification (2025)

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

FDAAug 15, 2025Nationwide• Exactech, Inc.

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