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,…
Read the official notice →- Date
- 2023-08-23
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-06
USOlympus 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 →- US
Olympus Corporation of the Americas recalls EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Recent reports of patient infection.
- 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 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 → - 2023-08-16
- US
Olympus Corporation of the Americas recalls Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display…
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V…
- 2023-08-09
- US
Olympus Corporation of the Americas recalls Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical…
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN,…Official notice →
Other drugs & medical recalls in the United States
- 2023-08-30
- US
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
cGMP deviations: Batch was released prior to approval.
- 2023-08-23
- US
Carefusion 2200 Inc recalls Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- US
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the…
FDA · DeviceAbbott Diabetes Care, Inc.US Nationwide distribution in the states of CA, FL, MI, NY, OH, TX, UT, VA.Official notice → - US
Medtronic Neurosurgery recalls Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Product labeling contains incorrect expiration date
FDA · DeviceMedtronic NeurosurgeryUS Nationwide distribution in the states of NJ, FL, CA, IL.Official notice → - US
Alcon Research, LTD. recalls Centurion FMS Pak
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
FDA · DeviceAlcon Research, LTD.Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - US
Conformis, Inc. recalls CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
30mm screws were labeled as 25mm screws.
FDA · DeviceConformis, Inc.US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, &…Official notice →