Olympus Corporation of the Americas recalls InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model…
Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be…
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number:…
- Classification
- Class II
- Units
- International distribution to the country of Japan.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-04-17
USOlympus Corporation of the Americas recalls Hemostasis Probe, Model: CD-B622LA
The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- 2024-04-03
- US
Olympus Corporation of the Americas recalls SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
FDA · DeviceOlympus Corporation of the AmericasDomestic: OUS Only; International distribution in the states of Australia,…Official notice → - US
Olympus Corporation of the Americas recalls Insufflation unit, UHI-4.
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
- 2024-03-06
- US
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- 2024-02-28
- US
Olympus Corporation of the Americas recalls ESG PK CUTTING FORCEPS, 5MM, 33CM
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2024-02-21
- US
Olympus Corporation of the Americas recalls Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus…
Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in…
Other drugs & medical recalls in the United States
- 2024-04-03
- US
Hologic, Inc. recalls Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter…
Use of assay along with plasma specimen may result in error code which would invalidate sample.
FDA · DeviceHologic, Inc.Worldwide - US Nationwide distribution in the states of CA, CT, FL, ID, IL,…Official notice → - US
Alcon Research, LLC recalls SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44,…
Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so…
- US
Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog…
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, IN.Official notice → - US
Bruder Healthcare Company, LLC recalls Thermalon Stye Compress, Item Number 24352
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
FDA · DeviceBruder Healthcare Company, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Bio-Rad Laboratories recalls Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
FDA · DeviceBio-Rad LaboratoriesUS Nationwide distribution in the states of PA, SD, TX, FL, MN.Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls stay-safe /Luer Lock Adapter 4 in
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
FDA · DeviceFresenius Medical Care Holdings, Inc.Domestic: Nationwide Distribution.Official notice →