Olympus Corporation of the Americas recalls EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Recent reports of patient infection.
Read the official notice →- Date
- 2023-09-06
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
- Classification
- Class II
- Units
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-10-11
USOlympus Corporation of the Americas recalls Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle,…
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of CN, DE, HK, IT,…Official notice →- 2023-09-06
- US
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- US
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL,…Official notice → - 2023-08-30
- US
Olympus Corporation of the Americas recalls The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC…
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body…
- 2023-08-23
- US
Olympus Corporation of the Americas recalls HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment…
Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment,…
- US
Olympus Corporation of the Americas recalls UroPass Ureteral Access Sheaths, 5 pieces/box
Dilator tips may break in the package and in patients during surgical procedures.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - United States Nationwide and the countries of South…Official notice →
Other drugs & medical recalls in the United States
- 2023-09-06
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice → - US
Skytron, LLC recalls GS70H Salus Surgical Table, Product Code 18-071-70
When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to…
FDA · DeviceSkytron, LLCWorldwide - US Nationwide distribution in the states of AL, AR, CA, CT, FL,…Official notice → - US
LeMaitre Vascular, Inc. recalls The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed…
Burrs (molding flash) on the cutter may tear the harvested vien
FDA · DeviceLeMaitre Vascular, Inc.International distribution to the countries of Belgium, France, Germany, and…Official notice → - US
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- US
Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000…
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
- US
RAYSEARCH LABORATORIES AB recalls RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows…
An issue was found in Software RayCare 5A, 5B, 6A, including service packs, where an allergy warning against medication substance (drug ingredient) will not be displayed as expected under certain circumstances
FDA · DeviceRAYSEARCH LABORATORIES ABUS Nationwide distribution in the state of TN.Official notice →