Drugs & medicalClass II

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".

Read the official notice →
Date
2024-04-03
Country
United States
Brand
Olympus Corporation of the Americas
Product
Insufflation unit, UHI-4.
Classification
Class II
Units
Domestic: 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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-05-08
  2. US
    Drugs & medicalClass II

    Olympus Corporation of the Americas recalls POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…

    Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to…

    FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.Official notice →
  3. 2024-04-17
  4. US
    Drugs & medicalClass II

    Olympus 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.

    FDA · DeviceOlympus Corporation of the AmericasInternational distribution only.Official notice →
  5. 2024-04-03
  6. US
    Drugs & medicalClass II

    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 →
  7. US
    Drugs & medicalClass II

    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…

    FDA · DeviceOlympus Corporation of the AmericasInternational distribution to the country of Japan.Official notice →
  8. 2024-03-06
  9. US
    Drugs & medicalClass II

    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.

    FDA · DeviceOlympus Corporation of the AmericasUS Nationwide distribution.Official notice →
  10. 2024-02-28
  11. US
    Drugs & medicalClass II

    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 →
All 114 Olympus Corporation of the Americas recalls →

Other drugs & medical recalls in the United States

  1. 2024-04-03
  2. US
    Drugs & medicalClass II

    Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

    FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice →
  3. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO

    A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal…

    FDA · DeviceBaxter Healthcare CorporationUS Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign)…Official notice →
  4. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Access Substrate, REF 81906, For use with the Access Immunoassay Systems

    On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman…

    FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice →
  5. US
    Drugs & medicalClass I

    Boston Scientific Corporation recalls Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010

    An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common…

    FDA · DeviceBoston Scientific CorporationUSOfficial notice →
  6. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I

    The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing…

    FDA · DeviceOrtho-Clinical DiagnosticsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  7. US
    Drugs & medicalClass II

    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 →
See all drugs & medical recalls →