Events

Recall of Device Recall Hobbs Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hobbs Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0824-06
  • Event Initiated Date
    2006-03-15
  • Event Date Posted
    2006-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45128
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code KOG
  • Reason
    Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
  • Action
    Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product.

Device

Device Recall Hobbs Medical
  • Model / Serial
    Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140;H11-05-141; H11-05-205.
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK
  • Product Description
    Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. || REF: 5030 and 5030S
  • Manufacturer
    Hobbs Medical, Inc.

Manufacturer

Hobbs Medical, Inc.
  • Manufacturer Address
    Hobbs Medical, Inc., 8 Spring St, Stafford Springs CT 06076-1505
  • Manufacturer Parent Company (2017)
    Hobbs Medical Inc.
  • Source
    USFDA