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Natus Brain Monitor Breakout Box (Natus) – Labeling Error (2025)

Natus received two complaints of left side labeling show impedance for right side.

FDAJun 18, 2025CA, IN, MO +4 more• Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

Green Silicone Seal (Olympus) – Sterilization Instructions (2025)

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

Low

FDAJun 18, 2025Nationwide• Olympus Corporation of the Americas

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Natus Brain Monitor Breakout Box (Natus) – Labeling Error (2025)

Green Silicone Seal (Olympus) – Sterilization Instructions (2025)

Ellik Latex Bulb (Olympus) – Sterilization Instructions (2025)

Bardex Lubri-Sil Catheter (C.R. Bard) – Drainage Obstruction (2025)

StrykeFlow Suction/Irrigator (Stryker) – Leakage Risk (2025)

Blue Silicone Seal (Olympus) – Sterilization Instructions (2025)

Medtronic CareLink Patient Connector (Medtronic) – Test Abort Issue (2025)

Osteotec Silicone Finger Implant (Osteotec) – Foreign Material (2025)

Dried Salted Roach Fish (Krasnyi Oktyabr) – Botulinum Risk (2025)

Ellik Evacuator (Olympus) – Sterilization Instructions (2025)

Ellik Evacuator Adapter (Olympus) – Sterilization Instructions (2025)

Honey Cough Syrup (Little Remedies) – Bacterial Contamination (2025)

Strawberry Mousse (SABORES FIT BAKERY) – undeclared allergens (2025)

Passion Fruit Mousse (SABORES FIT BAKERY) – undeclared allergens (2025)

Pecan Bars (Cheesecake Royale) – allergen labeling issue (2025)

Three Milk Mousse (SABORES FIT BAKERY) – undeclared allergens (2025)

MI Cancer Seek (Caris Life Sciences) – Test Result Inaccuracy (2025)

KWIK-STIK and LYFO DISK (Microbiologics) – Culture Media Mismatch (2025)

i-view Video Laryngoscope (Intersurgical) – Battery Depletion (2025)

Four Milk Mousse (SABORES FIT BAKERY) – undeclared allergens (2025)