Drugs & medicalClass III

Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Read the official notice →
Date
2023-09-13
Country
United States
Brand
Diversatek Healthcare
Product
ZVU Functional GI Software, REF: ZVU-3
Classification
Class III
Units
worldwide - US Nationwide distribution in the states of NJ, MN, TN, WA, KY,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Diversatek Healthcare recalls

  1. 2026-04-29
  2. US
    Drugs & medicalClass II

    Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

    The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

    FDA · DeviceDiversatek HealthcareUS: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ,…Official notice →
  3. 2025-08-20
  4. US
    Drugs & medicalClass III

    Diversatek Healthcare recalls Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct…

    FDA · DeviceDiversatek HealthcareWorldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the…Official notice →
  5. 2022-09-28
  6. US
    Drugs & medicalClass II

    Diversatek Healthcare recalls Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps,…

    M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

    FDA · DeviceDiversatek HealthcareUS Nationwide distribution.Official notice →
All 4 Diversatek Healthcare recalls →

Other drugs & medical recalls in the United States

  1. 2023-09-20
  2. US
    Drugs & medicalClass II

    VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by:…

    Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results

    FDA · DrugVistaPharm LLCDistributed nationwide to 68 consignees in the U.S.Official notice →
  3. US
    Drugs & medicalClass II

    BE PHARMACEUTICALS AG recalls Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC…

    Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.

    FDA · DrugBE PHARMACEUTICALS AGNationwide in the USAOfficial notice →
  4. 2023-09-13
  5. US
    Drugs & medicalClass II

    Aomori Olympus Co., Ltd. recalls Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR…

    The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

    FDA · DeviceAomori Olympus Co., Ltd.US Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

    The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

    FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ,…Official notice →
  7. US
    Drugs & medicalClass II

    Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

    Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

    FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.Official notice →
  8. US
    Drugs & medicalClass II

    Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact…

    Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric…

    FDA · DevicePhilips Ultrasound, Inc.Worldwide - US Nationwide distribution including in the states of FL, MN, AZ,…Official notice →
See all drugs & medical recalls →