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Showing 2381–2400 of 3039 results

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Welch Allyn Life2000 Compressor (Baxter Healthcare) – Cybersecurity Vulnerability (2025)

A cybersecurity vulnerability was discovered through internal testing.

FDAApr 7, 2025Nationwide• Baxter Healthcare Corporation

Microstream Advance CO2 Filter (Philips) – Adapter Disconnection Risk (2025)

Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.

FDAApr 7, 2025Nationwide• Philips North America Llc

WCM Series Molding Equipment (Apic Yamada) – FDA Compliance Issue (2025)

Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.

Low

FDAApr 7, 2025Nationwide• Apic Yamada America

Giant Instant Oatmeal (Vaughan Mills) – undeclared walnuts (2025)

Undeclared Allergen

Undeclared Allergen (walnuts), was not on outer packaging but was on the inner packaging of product.

Class IIModerate

FDAApr 4, 2025DE, MD, PA +2 more• VAUGHAN MILLS PACKAGING LTD.

Texas Olive Giardiniera (All American Trading) – contamination risk (2025)

The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.

Class IIModerate

FDAApr 4, 2025MS, TX• All American Trading Of Houston, Inc.

KliniTray Faxitron Plate (Klinika Medical) – Microbial Contamination (2025)

Potential for microbial contamination.

FDAApr 4, 2025Nationwide• Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany

Texas Olive Pepperoncini (All American Trading) – contamination risk (2025)

The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.

Class IIModerate

FDAApr 4, 2025MS, TX• All American Trading Of Houston, Inc.

INSPIRA AIR Balloon Dilation System (Integra LifeSciences) – Incorrect Product Packaging (2025)

Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.

FDAApr 4, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

KliniTray Tissue Margin Board (Klinika Medical) – Microbial Contamination (2025)

Potential for microbial contamination.

FDAApr 4, 2025Nationwide• Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany

Texas Olive Capers (All American Trading) – contamination risk (2025)

The recall is being carried out because repacking methods pose a possible risk of contamination. Sealing methods are not heat-sealed.

Class IIModerate

FDAApr 4, 2025MS, TX• All American Trading Of Houston, Inc.

Rover Mobile X-Ray System (Micro-X) – Generator Mechanism Failure (2025)

Potential for internal fastening mechanism within generator of mobile x-Ray to fail.

FDAApr 4, 2025NJ, WA, PR• Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia

SOLTIVE Pro SuperPul Laser Instrument (Olympus) – Treatment Parameter Deviation (2025)

Preset treatment parameters are not consistently being used in accordance with the IFU.

FDAApr 4, 2025Nationwide• Olympus Corporation of the Americas

ChlorproMAZINE Tablets (Zydus) – Impurity Above Limit (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

Class IIModerate

FDAApr 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Enhanced Verify Handset (Medtronic) – Communication Malfunction (2025)

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

FDAApr 3, 2025Nationwide• Medtronic Neuromodulation

Tibial Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

MAGEC 2 Rod (Globus Medical) – Incorrect Rod Diameter (2025)

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

FDAApr 3, 2025Nationwide• Globus Medical, Inc.

Distal Femoral Augment (Waldemar Link) – Missing Thread Screw (2025)

The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

FDAApr 3, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Frozen Chopped Cilantro (Supherb Farms) – foreign object risk (2025)

Potential contamination with foreign objects.

Class IIModerate

FDAApr 3, 2025Nationwide• Supherb Farms

IQF Cilantro Large (Supherb Farms) – foreign object risk (2025)

Potential contamination with foreign objects.

Class IIModerate

FDAApr 3, 2025Nationwide• Supherb Farms

Cookies and Cream Mochi (Mochidoki) – undeclared wheat/soy (2025)

Undeclared Gluten

Undeclared Wheat and Soy

Class IIModerate

FDAApr 3, 2025CT, OH, PA +1 more• Gordon Desserts DBA Mochidoki

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