Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when…
Read the official notice →- Date
- 2024-12-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-22
US
Olympus Corporation of the Americas recalls LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used…
Potential for distal tip tearing of the Mechanical Lithotriptor V.
US
Olympus Corporation of the Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be…
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
- 2024-12-25
US
Olympus Corporation of the Americas recalls Duravent Silicone Ventilation Tube. Model Number: 240075.
Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
FDA · DeviceOlympus Corporation of the AmericasAL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI.…Official notice →- 2024-11-27
US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number:…
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors…
FDA · DeviceOlympus Corporation of the AmericasDomestic: US Nationwide Distribution.Official notice →- 2024-11-20
US
Olympus Corporation of the Americas recalls Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX,…
Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →US
Olympus Corporation of the Americas recalls Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →
Other drugs & medical recalls in the United States
- 2024-12-18
US
Biocompatibles UK, Ltd. recalls Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer…
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
- 2024-12-11
US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
US
Becton Dickinson & Co. recalls BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro…
BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely resistant result for ampicillin…
FDA · DeviceBecton Dickinson & Co.Worldwide - US Nationwide distribution in the states of CA, GA, IL, KY, MA,…Official notice →US
Advanced Medical Solutions Ltd. recalls MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE…
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
FDA · DeviceAdvanced Medical Solutions Ltd.U.S. Nationwide distribution in the states of IL, TX, and VA.Official notice →US
GE Healthcare (China) Co., Ltd. recalls GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical,…
US
Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in…
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →