Drugs & medicalClass II

Karl Storz Endoscopy recalls Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

Flexible intubation endoscopes sterility assurance can not be confirmed.

Read the official notice →
Date
2023-09-27
Country
United States
Brand
Karl Storz Endoscopy
Product
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Classification
Class II
Units
Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Karl Storz Endoscopy recalls

  1. 2024-05-22
  2. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

    Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then…

    FDA · DeviceKarl Storz EndoscopyWorldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX,…Official notice →
  3. 2024-04-10
  4. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

    Inadequate reprocessing validation evidence

    FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA,…Official notice →
  5. 2023-12-27
  6. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

    The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

    FDA · DeviceKarl Storz EndoscopyUS: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI,…Official notice →
  7. 2023-06-28
  8. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal…

    Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes…

    FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of IN, MS, MN,…Official notice →
  9. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A

    Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes…

    FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AR, AZ,…Official notice →
  10. 2022-06-15
  11. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF…

    The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.

    FDA · DeviceKarl Storz EndoscopyWorldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice →
All 17 Karl Storz Endoscopy recalls →

Other drugs & medical recalls in the United States

  1. 2023-09-27
  2. US
    Drugs & medicalClass II

    Aquila Corporation recalls APK2 Pressure-Sensing Wheelchair Cushions

    Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.

    FDA · DeviceAquila CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →
  3. US
    Drugs & medicalClass II

    SenTec AG recalls Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3…

    During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

    FDA · DeviceSenTec AGUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass I

    Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator

    Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption…

    FDA · DeviceHamilton Medical, Inc.Distribution US nationwide, including Puerto Rico. OUS: Not providedOfficial notice →
  6. US
    Drugs & medicalClass II

    HUMANRACE recalls Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100%…

    Subpotent Drug: Product does not contain SPF that is declared on the label.

    FDA · DrugHUMANRACENationwide in the USA, Spain, Italy, UK, and France.Official notice →
  7. US
    Drugs & medicalClass I

    Novartis Pharmaceuticals Corp. recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue…

    Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

    FDA · DrugNovartis Pharmaceuticals Corp.Nationwide in the USAOfficial notice →
See all drugs & medical recalls →