Olympus Corporation of the Americas recalls Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source,…
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may…
Read the official notice →- Date
- 2024-01-17
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Olympus Corporation of the Americas recalls
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USOlympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S,…
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Europe,…Official notice →- US
Olympus Corporation of the Americas recalls SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in…
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS…Official notice → - US
Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
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Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
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Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop…
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FDA · DeviceOlympus Corporation of the AmericasUS: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.Official notice → - 2023-12-20
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Other drugs & medical recalls in the United States
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Immunostics, Inc. recalls Detector H. Pylori, Catalog Number IHP-30
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Medtronic Xomed, Inc. recalls NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d)…
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