Drugs & medicalClass II

Integra LifeSciences Corp. recalls CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration…

Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment

Read the official notice →
Date
2024-07-03
Country
United States
Brand
Integra LifeSciences
Product
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of…
Classification
Class II
Units
Nationwide Foreign: Argentina Australia Bangladesh Bangladesh Belgium Bolivia…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Integra LifeSciences recalls

  1. 2024-10-16
  2. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube…

    There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC,…Official notice →
  3. 2024-08-14
  4. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi"…

    Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized…

    FDA · DeviceIntegra LifeSciences Corp.The devices are only sold in the US. The following states have received the…Official notice →
  5. 2024-07-17
  6. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

    Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

    FDA · DeviceIntegra LifeSciences Corp.Domestic: NY, OH, & DC.Official notice →
  7. 2024-06-19
  8. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally…

    Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide - US Nationwide distribution in the state of TX and the countries of…Official notice →
  9. 2024-05-29
  10. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

    Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of CA, BE, CL.Official notice →
  11. 2024-03-06
  12. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the…

    A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Austria, Bahamas,…Official notice →
All 33 Integra LifeSciences recalls →

Other drugs & medical recalls in the United States

  1. 2024-07-03
  2. US
    Drugs & medicalClass II

    Roche Diabetes Care, Inc. recalls Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper…

    The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as…

    FDA · DeviceRoche Diabetes Care, Inc.Nationwide and WorldwideOfficial notice →
  3. US
    Drugs & medicalClass II

    SIGHT DIAGNOSTICS LTD recalls Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC…

    One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside…

    FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and…Official notice →
  4. US
    Drugs & medicalClass II

    GE Healthcare Finland Oy recalls CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f)…

    GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the…

    FDA · DeviceGE Healthcare Finland OyWorldwide distribution.Official notice →
  5. US
    Drugs & medicalClass I

    Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model…

    Potential for coils to heat up and harm patients (burn).

    FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan,…Official notice →
  6. US
    Drugs & medicalClass I

    Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator

    There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

    FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the country of Germany.Official notice →
  7. US
    Drugs & medicalClass I

    Baxter Healthcare Corporation recalls Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002,…

    Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the…

    FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution.Official notice →
See all drugs & medical recalls →