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Power Knee (Ossur) – battery failure risk (2023)

Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.

High

FDADec 26, 2023Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Superpotent drug: Assay results were slightly above specification at the time zero point.

Class IIILow

FDADec 26, 2023Nationwide• Amerisource Health Services LLC

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Power Knee (Ossur) – battery failure risk (2023)

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Robitussin Honey CF Max Non-Drowsy (Haleon) – Microbial Contamination (2023)

Robitussin Honey CF Max Nighttime (Haleon) – Microbial Contamination (2023)

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Eleos Collar Stem (Onkos) – mislabeling problem (2023)

Aligned Ocular Pack (Windstone) – saline sterility concern (2023)

Aligned Closure Kit (Windstone) – saline sterility concern (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

Aligned Lower Extremity Pack (Windstone) – saline sterility issue (2023)

GE Voluson Probe (GE Healthcare) – image artifact risk (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Allograft Filler Tube (Musculoskeletal) – filling process risk (2023)

Baxter Exactamix Pro (Baxter) – overfill software error (2023)

Henry Schein Masks (AMD Medicom) – production equipment problem (2023)

Phantom TTC Nail (Paragon 28) – pre-sterilization distribution (2023)

Terumo HydroPearl (MicroVention) – manufacturing process fault (2023)

Medline Blood Culture Bottle Kit (Medline) – kit quality issue (2023)