Events

Recall of Device Recall Bakers Pride Model E300 Speed Ovens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Standex Intl Corp.

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
    77581
  • Event Risk Class
    Class 2
  • Event Number
    Z-2614-2017
  • Event Initiated Date
    2017-01-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156620
  • 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
    Microwave oven, consumer - Product Code RCR
  • Reason
    It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
  • Action
    The Standex Cooking Solutions Group plans to replace all 149 Bakers Pride Model E300 Speed Ovens remaining in the field as follows : 1.Product design changes include (a) an updated interlock switch mounting that reduces the effects of shipping and handling on switch positioning; (b) a revised mechanism for the secondary interlock switch to prevent operation by any part of the human body or any object with a straight insertable length of 3.9 inches. A 200,000-cycle leakage measurement is conducted and will be finished by July 31, 2017. 2.The updated replacement oven will be shipped with the improved, stronger bracing materials and added cover over the handle with markings and changes in the door mechanism. 3.New compliant ovens will be delivered by an installer to distributors and owners. 4.All shipping and installation costs for delivery of the new units and return of the old units will be paid by Standex International Corporation. 5.The updated and corrected pages of the Service Manual and Owners Manual will be included with the delivery of the replacement oven, and the corrected warning label and Certification label will be permanently affixed to the replacement ovens. 6.Standex International Corporation expects to deliver the replacement units after testing, which will be completed by July 31, 2017. Distributors and customers will then be given a period of 4 weeks to return the old unit. 7.All returned ovens will be updated to revised construction and subjected to the full Unit Test Procedure required for new products. Ovens that cannot be updated will be destroyed. 8.Progress reports will be provided to FDA on the 15th of every month until all non-compliant ovens have been replaced with new compliant ovens, returned to the factory and modified to the revised and compliant construction, as verified by conducting the Unit Test Procedure. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and

Device

Device Recall Bakers Pride Model E300 Speed Ovens
  • Model / Serial
    S/N: 562071609002 562071706001 562071608015 562071609003 562071608014 562071609001
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution
  • Product Description
    Standex International Bakers Pride Microwave Ovens Model E300
  • Manufacturer
    Standex Intl Corp

Manufacturer

Standex Intl Corp
  • Manufacturer Address
    Standex Intl Corp, 11 Keewaydin Dr, Salem NH 03079-2999
  • Source
    USFDA