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Showing 2761–2780 of 68218 results

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iGo2 DC Car Adapter (Medical Depot) – Power Supply Risk (2025)

Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

FDAApr 11, 2025Nationwide• Medical Depot Inc.

TufTex Embolectomy Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Pruitt Irrigation Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

Moderate

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Pruitt Occlusion Catheter (LeMaitre) – Seal Integrity (2025)

During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

FDAApr 11, 2025Nationwide• LeMaitre Vascular, Inc.

Codman Craniotomy Kit (Integra) – Weld Integrity (2025)

Inadequate weld that can potentially cause the product to disassemble.

FDAApr 11, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Codman Disposable Perforator (Integra) – Weld Integrity (2025)

Inadequate weld that can potentially cause the product to disassemble.

FDAApr 11, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

MedicaLyte Bicarbonate (Nipro) – Foreign Matter Risk (2025)

Potential for the presence of visible foreign matter.

FDAApr 11, 2025Nationwide• Nipro Renal Soultions USA, Corporation

Gluten Free Vanilla Cake (Emily Kate's) – foil fragment (2025)

Foreign material (foil) found in cake slices

Class IIModerate

FDAApr 11, 2025IN, WI• Emily Kate's Foods

Gluten Free Carrot Cake (Emily Kate's) – foil fragment (2025)

Foreign material (foil) found in cake slices

Class IIModerate

FDAApr 11, 2025IN, WI• Emily Kate's Foods

Blueprint Software (Tornier) – Case Access Issue (2025)

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

FDAApr 10, 2025Nationwide• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

3M Ranger Blood Warming Set (3M) – Flow Rate Clarification (2025)

Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.

FDAApr 10, 2025Nationwide• 3M Company

CADD-Solis VIP Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis VIP Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

AirLife Infant Circuit (Vyaire) – Adapter Disconnect (2025)

Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.

FDAApr 10, 2025Nationwide• Vyaire Medical

Premium Non-Dairy Creamer (Momo Tea) – undeclared milk (2025)

Product does not declare the allergen, milk, on the label.

FDAApr 10, 2025CT, NJ, NY• MOMO TEA INC

Testosterone Cypionate Injection (Eugia US LLC) – Crystal Dissolution Issue (2025)

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

Class IIModerate

FDAApr 10, 2025Nationwide• Eugia US LLC

ClomiPRAMINE Hydrochloride Capsules (Lupin) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

Class IIModerate

FDAApr 10, 2025Nationwide• Lupin Pharmaceuticals Inc.

Levothyroxine Sodium Tablets (Accord Healthcare) – Subpotent Medication (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 50mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine 88mcg (ACCORD) – Subpotent (2025)

Subpotent

Class IIModerate

FDAApr 10, 2025Nationwide• ACCORD HEALTHCARE, INC.

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