The Recall Desk

FDA (Devices) recall action 88440

Pentax of America Inc recalled 2 products on 2021-09-22

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-09-22
Critical
0
Units
57,698

Why these products were recalled

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2021-09-22

    Pentax Upper GI Endoscopes and Colonoscopes: Updated Reprocessing Instructions

    Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.

    Product
    Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-22

    Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions

    Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.

    Product
    Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with…
    Category
    Distribution
    0 states