Olympus Corporation of the Americas recalls Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
- Classification
- Class II
- Units
- US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-27
USOlympus 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 → - 2024-11-06
- US
Olympus Corporation of the Americas recalls Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a…
Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the…
- US
Olympus Corporation of the Americas recalls Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
- 2024-10-30
- US
Olympus Corporation of the Americas recalls EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate…
Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon,…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-11-06
- US
Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA · DeviceNihon Kohden America IncU.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT,…Official notice → - US
Remel, Inc recalls remel BactiDrop Acridine Orange, REF 21502, 50 per package.
A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
FDA · DeviceRemel, IncDistribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was…Official notice → - US
Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access…
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
FDA · DeviceBeckman Coulter, Inc.Distribution was made nationwide to the U.S., including Puerto Rico. There was…Official notice → - US
Westmed, Inc. recalls 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders…
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
FDA · DeviceWestmed, Inc.U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH,…Official notice → - US
Integra LifeSciences Corp. recalls Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Out of specification endotoxin levels.
- US
Ambu Inc. recalls Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number…
Ambu has received complaints on Ambu¿ VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of complications during intubation and potential airway injury.