Drugs & medicalClass II

Olympus Corporation of the Americas recalls EVIS EXERA III Gastrointestinal Videoscope

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Read the official notice →
Date
2023-11-15
Country
United States
Brand
Olympus Corporation of the Americas
Product
EVIS EXERA III Gastrointestinal Videoscope
Classification
Class II
Units
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2024-01-17
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…

    Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

    FDA · DeviceOlympus Corporation of the AmericasNationwideOfficial notice →
  3. 2023-12-27
  4. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop…

    Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

    FDA · DeviceOlympus Corporation of the AmericasUS: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.Official notice →
  5. 2023-12-20
  6. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

    Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

    FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA,…Official notice →
  7. 2023-11-15
  8. US
    Drugs & medicalClass I

    Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distributionOfficial notice →
  9. 2023-10-25
  10. US
    Drugs & medicalClass I

    Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

    There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal…

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
  11. 2023-10-18
  12. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including…

    Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
All 114 Olympus Corporation of the Americas recalls →

Other drugs & medical recalls in the United States

  1. 2023-11-22
  2. US
    Drugs & medicalClass II

    Omega & Delta Co., Inc. recalls Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

    Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

    FDA · DrugOmega & Delta Co., Inc.Distributed in Puerto Rico only.Official notice →
  3. 2023-11-15
  4. US
    Drugs & medicalClass II

    Maquet Medical Systems USA recalls Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

    It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual…

    FDA · DeviceMaquet Medical Systems USAUS Nationwide.Official notice →
  5. US
    Drugs & medicalClass II

    Carestream Health, Inc. recalls The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system…

    There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self…

    FDA · DeviceCarestream Health, Inc.US Nationwide. Global Distribution.Official notice →
  6. US
  7. US
    Drugs & medicalClass I

    Cordis US Corp recalls Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

    Non-sterile product labeled as sterile was distributed.

    FDA · DeviceCordis US CorpUS Distribution to: OKOfficial notice →
  8. US
    Drugs & medicalClass II

    Young Dental Manufacturing I, LLC recalls CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

    one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

    FDA · DeviceYoung Dental Manufacturing I, LLCUS: IN, TN, MOOfficial notice →
See all drugs & medical recalls →