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…
Read the official notice →- Date
- 2023-08-16
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other…
- Classification
- Class II
- Units
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-08-30
USOlympus 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 → - 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 → - 2023-07-26
- US
Olympus Corporation of the Americas recalls Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- 2023-06-28
- US
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog…
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The…
Other drugs & medical recalls in the United States
- 2023-08-16
- US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material…
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable…
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
ORTHO-CLINICAL DIAGNOSTICS recalls VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
FDA · DeviceORTHO-CLINICAL DIAGNOSTICSWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases,…
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this…
- US
B. Braun Medical Inc. recalls 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
- US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey…
Out of Specification result observed in content uniformity testing
- 2023-08-09
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA,…
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →