FDA Device Intelligence
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Nasopharyngoscope (Flexible Or Rigid)

FDA product code EOB · Class 2 · Ear, Nose, Throat

1,313
Registered devices
7,689
Adverse events
8
Recalls
162
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2024-04-03Olympus Corporation of the AmericasPotential for distal end of the sheath to break off during a procedure.
2024-01-16Olympus Corporation of the AmericasJapanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order t
2023-12-04Shirakawa Olympus Co., Ltd.Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
2022-04-01Karl Storz EndoscopyFailure to achieve the expected six-log reduction in microorganisms following the disinfection process.
2020-05-05Olympus Corporation of the AmericasProducts repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
2016-04-06Pentax Medical CompanyPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's
2011-12-27Vision-Sciences, Inc.Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-i
2011-12-27Vision-Sciences, Inc.Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-i

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.