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Showing 801–820 of 3039 results

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TENACIO Pump without InhibiZone (Boston Scientific) – Inflation Issue (2025)

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

FDASep 11, 2025Nationwide• Boston Scientific Corporation

Sodium Chloride Injection (Excelsior) – Concentration Deviation (2025)

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

FDASep 11, 2025Nationwide

ECHELON Linear Cutters (Ethicon) – Unsterilized Devices (2025)

The devices were shipped unsterilized.

Moderate

FDASep 11, 2025Nationwide• Ethicon Endo-Surgery Inc

Olympus Bronchovideoscope BF-Q170 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Italian Mixed Vanilla Cookies (Gina Marie Bakery) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Italian Sesame Cookies (Gina Marie Bakery) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Der Mutterschaf Cheese (Goot Essa) – Listeria Contamination (2025)

The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.

FDASep 10, 2025CT, MT, NJ +1 more• GOOT ESSA, LLC

Vanilla Apricot Jam Cookies (Gina Marie Bakery) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Red 40 and Yellow 6

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Medline Anesthesia Set (Medline) – IV Set Leakage (2025)

Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

FDASep 10, 2025Nationwide

Goodles Truffle Cheddar Shells (Gooder Foods) – Undeclared Cashews (2025)

Undeclared Allergen

Undeclared allergens (cashews).

FDASep 10, 2025AL, AZ, AR +34 more• Gooder Foods, Inc.

Toasted Cherry Biscotti (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Contains undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

Vanilla Cookies with Raspberry Peach Jam (Gina Marie Bakery) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Red 3 and Blue 1

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

TactiFlex Ablation Catheter (Abbott) – Tip Detachment Risk (2025)

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

FDASep 10, 2025Nationwide• Abbott

Vanilla Chocolate Dipped Cookies (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

Goodles Vegan White Cheddar Spirals (Gooder Foods) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared allergens (milk).

FDASep 10, 2025AL, AZ, AR +34 more• Gooder Foods, Inc.

Toasted Almond & Cherry Biscotti (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

BioPro Endo Head (Ceramic) (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDASep 9, 2025MI, TX• BioPro, Inc.

NOxBOXi Nitric Oxide System (NOXBOX) – Flow Sensor Fluctuations (2025)

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

FDASep 9, 2025TN• NOXBOX LTD

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDASep 9, 2025MI, TX• BioPro, Inc.

BioPro Bipolar Head (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDASep 9, 2025MI, TX• BioPro, Inc.

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