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…
Read the official notice →- Date
- 2024-10-30
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 → - 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.
- 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.
- 2024-09-18
- US
Olympus Corporation of the Americas recalls Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using…
Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions…
- 2024-08-14
- US
Olympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer…
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.Official notice →
Other drugs & medical recalls in the United States
- 2024-10-30
- US
Mckesson Medical-Surgical Inc. Corporate Office recalls Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended…
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
FDA · DeviceMckesson Medical-Surgical Inc. Corporate OfficeUS Nationwide distribution in the state of DC.Official notice → - US
Medtronic Neuromodulation recalls SynchroMed II Infusion Pump. Product Number: 8637-20
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
FDA · DeviceMedtronic NeuromodulationUS Nationwide distribution in the state of Mississippi.Official notice → - US
B-K Medical A/S recalls bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery…
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
FDA · DeviceB-K Medical A/SWorldwide - US Nationwide - There was also government/military distribution…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile;…
Product has been identified as having holes in the packaging.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of India and Panama.Official notice → - US
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to…
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
FDA · DeviceDatex-Ohmeda, Inc.Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3)…
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.