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Food Club Pizza Cheese Blend (Great Lakes) – Metal Fragments (2025)

Potential metal fragments from supplier raw material (downstream recall)

FDAOct 3, 2025AL, AZ, AR +29 more• Great Lakes Cheese Co Inc

TruDi Navigation System Adapter (Integra) – configuration risk (2025)

It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.

Moderate

FDAOct 3, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

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Food Club Pizza Cheese Blend (Great Lakes) – Metal Fragments (2025)

TruDi Navigation System Adapter (Integra) – configuration risk (2025)

Mozzarella Shredded Cheese (Great Lakes) – Metal Fragments (2025)

Mozzarella Provolone Cheese (Great Lakes) – Metal Fragments (2025)

Shanghai Style Plain Noodle (Twin Marquis) – Undeclared Allergens (2025)

Italian Shredded Cheese Blend (Great Lakes) – Metal Fragments (2025)

CEREPAK Detachable Coil System (Cerenovus) – detachment failure (2025)

Gluten Free Bean & Rice Burrito (Amy's Kitchen) – Foreign Objects (2025)

IV Administration Set (ICU Medical) – missing shutoff valve (2025)

Magseed Pro 7cm Marker (Endomagnetics) – fiber contamination (2025)

Impella Controller (Abiomed) – cybersecurity vulnerability (2025)

MAS Omni CARDIO Controls (Microgenics) – variability issue (2025)

LigaSure Blunt Tip Sealer (Medline) – material trapping (2025)

ProxiDiagnost N90 (Philips) – carriage movement issue (2025)

ReQuest Measles IgG Test (Quest) – distribution issue (2025)

UniCel DxI 600 Analyzer (Beckman) – motion error risk (2025)

UniCel DxI 800 Analyzer (Beckman) – motion error risk (2025)

LigaSure Impact Curved Jaw (Medline) – material trapping (2025)

CombiDiagnost R90 (Philips) – carriage movement issue (2025)

MAGNETOM Cima.X Upgrade (Siemens) – ice blockage potential (2025)