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U.S. Department of Health and Human Services

Class 2 Device Recall Junction Boxes

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  Class 2 Device Recall Junction Boxes see related information
Date Initiated by Firm March 15, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 on September 15, 2017
Recall Number Z-2402-2016
Recall Event ID 73577
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Junction Boxes,

Product Usage:
The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Code Information Model #'s:1104343 & 1104345
Recalling Firm/
Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact
Manufacturer Reason
for Recall
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance.
Quantity in Commerce 1,011 units
Distribution US Nationwide Distribution including DC and PR. Internationally Canada.
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.