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Showing 4241–4260 of 4465 results

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Trader Joe's Low Sodium Albacore Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Genova Yellowfin Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Solid Light Yellowfin Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Albacore Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

HEB Solid White Albacore Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Genova Yellowfin Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Albacore Tuna in Olive Oil – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Van Camp's Solid Light Yellowfin Tuna (Chicken of the Sea) – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Trader Joe's Salted Albacore Tuna – Botulinum Risk (2025)

Product's easy-pull lid was not secured properly and may cause the product to become adulterated with the hazard clostridium botulinum.

Class IIModerate

FDAFeb 4, 2025Nationwide• Chicken of the Sea; Thai Union

Access Erythropoietin (Beckman Coulter) – reagent lot variation (2025)

Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.

FDAFeb 3, 2025AL, AZ, AR +21 more• Beckman Coulter, Inc.

TBS iNsight (Medimaps) – calculation variability (2025)

Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.

FDAFeb 3, 2025AL, AZ, CA +21 more• Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland

New Flyer XDE60 (New Flyer) – fuel system hose (2025)

New Flyer of America, Inc. (New Flyer) is recalling certain 2023-2024 XDE60, 2024 XD35, XD40, and XD60 transit buses equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.

NHTSAFeb 3, 2025Nationwide• NEW FLYER

Temsa TS35 (Temsa) – fuel filter hose (2025)

Temsa is recalling certain 2024 TS35 vehicles equipped with Cummins L9 diesel engines. The remote fuel filter hoses may separate from the fitting, causing a fuel leak and an engine stall.

NHTSAFeb 3, 2025Nationwide• TEMSA

VOCSN Ventilators (Ventec) – servicing part issue (2025)

Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

FDAFeb 3, 2025CA, IN, MO +1 more• Ventec Life Systems, Inc.

CardioMEMS HF System (St. Jude Medical) – data migration (2025)

Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.

FDAFeb 3, 2025Nationwide• St. Jude Medical

HemosIL LMW Heparin Controls (Instrumentation Laboratory) – QC results (2025)

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

FDAFeb 3, 2025Nationwide• Instrumentation Laboratory

LIFEPAK 20e (Physio-Control) – keypad installation (2025)

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

FDAFeb 3, 2025WV• Physio-Control, Inc.

MiniMed 720G Insulin Pump (Medtronic) – delivery risk (2025)

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

SIGNA MR380 MRI System (GE Healthcare) – SAR monitoring (2025)

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

FDAJan 31, 2025Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

Paradigm Insulin Pump MMT-522/551/722 (Medtronic) – delivery risk (2025)

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

FDAJan 31, 2025Nationwide• Medtronic MiniMed, Inc.

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