Olympus recalls Single Use Distal Cover MAJ-2315 used with EVIS EXERA III Duodenovideoscopes due to risk of detachment causing mucosal injury, tissue damage, bleeding, perforation, or obstruction requiring urgent medical intervention.
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
Olympus is recalling Single Use Distal Cover MAJ-2315 that may detach during use, potentially causing gastrointestinal injury, bleeding, or perforation that requires immediate medical attention. This recall affects duodenoscopes used in endoscopic procedures.
The Single Use Distal Cover MAJ-2315 may detach unexpectedly during endoscopic procedures. If the cover remains in the gastrointestinal tract, it can cause mucosal injury, tissue damage, bleeding, perforation, or obstruction requiring urgent medical removal. Detachment in the oral cavity may also lead to aspiration, airway obstruction, or respiratory distress.
Endoscopists and medical professionals who use Olympus EVIS EXERA III Duodenovideoscopes with the recalled Single Use Distal Cover MAJ-2315 are most at risk. Patients undergoing endoscopic procedures with this specific cover could experience serious injury.
Check if your duodenoscope is labeled with the model EVIS EXERA III TJF-Q190V and uses the Single Use Distal Cover MAJ-2315. The recall covers all units with UDI: 04953170441271.
Immediately stop using the Single Use Distal Cover MAJ-2315 with EVIS EXERA III Duodenovideoscopes as it may detach during use.
The Single Use Distal Cover MAJ-2315 may detach unexpectedly during endoscopic procedures, causing potential injury to the gastrointestinal tract or airway requiring urgent medical intervention.
Detachment can lead to mucosal injury, tissue damage, bleeding, perforation, or obstruction that requires urgent medical removal. In the oral cavity, it may cause aspiration, airway obstruction, or respiratory distress.
Check if your duodenoscope is labeled with the model EVIS EXERA III TJF-Q190V and uses the Single Use Distal Cover MAJ-2315. The recall covers all units with UDI: 04953170441271.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1071-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1071-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
