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Ellik Evacuator Tubing (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

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

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

Low

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

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

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

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

Nutra Calm Capsules (Professional Botanicals) – Magnesium Salicylate (2025)

Total Comfort Capsules (Professional Botanicals) – Magnesium Salicylate (2025)

Tense-X Capsules (Professional Botanicals) – Magnesium Salicylate (2025)

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

Dark Chocolate Nonpareils (Lipari Foods) – Undeclared Milk (2025)

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

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

QuickVue Strep A Test (Quidel) – False Positive Risk (2025)

Medtronic SmartLink Software (Medtronic) – Display Error Update (2025)

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

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

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

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

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

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

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

SwabFlush Prefilled Syringe (Medline) – SwabCap Seal Issue (2025)