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,…
Read the official notice →- Date
- 2024-10-30
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of…
- Classification
- Class II
- Units
- Worldwide Distribution: US distribution to states of: CA, FL, IL, NJ, NY, PA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-06
USOlympus 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).
- 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 Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
- US
Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…Official notice → - 2024-10-23
- US
Olympus Corporation of the Americas recalls EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light…
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
Other drugs & medical recalls in the United States
- 2024-11-06
- US
BLI International, Inc. recalls Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Superpotent Drug: Stability failure for assay at 6 months test time-point.
FDA · DrugBLI International, Inc.Product was shipped to two private label customers ( OH & MO) as a final…Official notice → - US
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC…
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- 2024-10-30
- US
Boston Scientific Corporation recalls Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac…
Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.
FDA · DeviceBoston Scientific CorporationNationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY,…Official notice → - US
Spectrum Medical Ltd. recalls Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing.…
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
FDA · DeviceSpectrum Medical Ltd.US Nationwide distribution including in the states of Alabama, California,…Official notice → - US
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recalls A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the…
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may…
FDA · DevicePolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Japan, South Africa.Official notice → - US
Ad-Tech Medical Instrument Corporation recalls AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol.…
FDA · DeviceAd-Tech Medical Instrument CorporationUS Nationwide distribution in the states of CA, OH.Official notice →