4 Earth Farms formerly Mcl Fresh Inc Recalls

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Organic Vegetable Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Vegetable Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

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Class IHigh

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Broccoli Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Organic Broccoli Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Stir Fry Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Organic Carrots (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Organic Vegetable Medley (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Organic Broccoli Slaw (4 Earth Farms) – E. coli risk (2024)

potential contamination with E. coli O121:H19

FDANov 18, 2024CA, FL, IL +5 more• 4 Earth Farms formerly Mcl Fresh Inc

Spectral CT Scanner (Philips) – Procedure Box Risk (2024)

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

High

FDANov 16, 2024Nationwide• Philips North America Llc

mint Lesion Software 3.9.0 (Mint Medical) – Orientation Label Error (2024)

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Moderate

FDANov 15, 2024Nationwide• Mint Medical GmbH Friedrich-Ebert-Str. 2 Dossenheim Germany

L'Oven Fresh Keto Multiseed Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

L'Oven Fresh Keto Original Tortillas (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

Duloxetine Capsules 30 mg (Amerisource) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Duloxetine Capsules 60 mg (Amerisource) – Impurity Concern (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Duloxetine Capsules (Amerisource) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

FDANov 14, 2024OH, PA, PR• Amerisource Health Services LLC

Bakestone Brothers Pita Bread (Rise Baking) – Metal Contamination (2024)

Foreign Material (metal)

FDANov 14, 2024CT, KS, MN +2 more• Rise Baking Company, LLC dba The New French Bakery Inc.

Magnesium Flex Reagent Cartridge (Siemens) – Lot Quality Issue (2024)

Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out

Moderate

FDANov 12, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Philips Allura Xper Systems (Philips) – Lifetime Extension Issue (2024)

Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.

High

FDANov 11, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Aspirin Chewable Tablet (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.