Class 2 Device Recall Bakers Pride Model E300 Speed Ovens

• Date Initiated by Firm: January 01, 2017
• Create Date: July 14, 2017
• Recall Status: Terminated on February 12, 2020
• Recall Number: Z-2614-2017
• Recall Event ID: 77581
• Product Classification: Microwave oven, consumer - Product Code RCR
• Product: Standex International Bakers Pride Microwave Ovens Model E300
• Code Information: S/N: 562071609002 562071706001 562071608015 562071609003 562071608014 562071609001
• Recalling Firm/ Manufacturer: Standex Intl Corp; 11 Keewaydin Dr; Salem NH 03079-2999
• For Additional Information Contact: 603-893-9701
• Manufacturer Reason for Recall: It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
• FDA Determined Cause: Device Design
• 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
• Quantity in Commerce: 149
• Distribution: US Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.