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Showing 2521–2540 of 68218 results

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SmartRelease ESTR (MicroAire) – Unintended Blade Cut (2025)

Laceration Risk

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

FDAMay 7, 2025Nationwide• MicroAire Surgical Instruments, LLC

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

OBM00002 OBM DAB (XLTEK) – Backwards Electrode Labels (2025)

Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.

High

FDAMay 7, 2025Nationwide• Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Geoduck Chowder Base (Vern's Foods) – Undeclared Anchovies (2025)

The ingredients statement declares fish sauce but does not declare anchovies. The Contains statement does not declare fish (anchovies).

Class IIModerate

FDAMay 7, 2025IN, WA• Vern's Foods & Farm

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

Unreleased software versions were installed on distributed devices without verification or validation.

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Bromfenac Ophthalmic Solution (Alembic) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAMay 7, 2025Nationwide• Alembic Pharmaceuticals Limited

Jumbo Pumpkin Seeds (Organic Traditions) – Salmonella Risk (2025)

Product may be contaminated with Salmonella

FDAMay 7, 2025NJ, NY, VA• Advantage Health Matters Inc.

Simplera Sensor (Medtronic) – Sterility Compromise (2025)

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

FDAMay 7, 2025Nationwide• Medtronic MiniMed, Inc.

HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

FDAMay 6, 2025AZ, CA, CO +19 more• Hardy Diagnostics

PhenoMATRIX (Copan) – Unapproved Software (2025)

AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

FDAMay 6, 2025Nationwide• Copan WASP Via Achille Grandi

Powered Laser Surgical Instrument (Olympus) – Thermal Incident Risk (2025)

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

FDAMay 6, 2025Nationwide• Olympus Corporation of the Americas

Affinity 4 Birthing Bed (Baxter) – Signal Wire Crimp (2025)

There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.

FDAMay 6, 2025Nationwide• Baxter Healthcare Corporation

Apple & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

Frozen Shrimp (Chicken of the Sea) – Undeclared Sulfites (2025)

Undeclared Allergen

Frozen Raw Peeled & Deveined tail on, shrimp contains undeclared sulfites

FDAMay 6, 2025CO, IN• TRI-UNION FROZEN PRODUCTS INC DBA CHICKEN OF THE SEA FROZEN FOOD

Endurance Boost Capsules (EnShiShiXiangNi) – Undeclared Sildenafil (2025)

Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).

FDAMay 6, 2025Nationwide• EnShiShiXiangNiShangMaoYouXianGongSi

Tortilla de Mesa (Tortilleria Xpress) – Undeclared Soy (2025)

Undeclared Allergen

Undeclared soy allergen

Class IIModerate

FDAMay 6, 2025TX• Tortilleria Xpress Inc

Peanut Butter Jam Cookie (Sweetheart USA) – Undeclared Sesame (2025)

Undeclared Allergen

Undeclared sesame

Class IIModerate

FDAMay 6, 2025IN, OH• Sweetheart USA, LLC

Celery & PB Snack Cup (GBC Food Services) – Plastic Contamination (2025)

Foreign Material (plastic)

Class IIModerate

FDAMay 6, 2025GA, IN, MI +1 more• GBC Food Services, LLC

EVIS EXERA III Duodenovideoscope (Olympus) – Contamination Risk (2025)

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.

FDAMay 5, 2025Nationwide• Olympus Corporation of the Americas

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