FDA (Devices) recall action 93335
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
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.
Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.
Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
24 Olympus EVIS EXERA III colonoscopes distributed to six states are recalled due to improperly repaired connectors that may cause image loss, decreased suction, or improper reprocessing, potentially exposing patients to contaminated equipment.
Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.