FDA Medical Device Recalls (openFDA)
Invacare Corporation: 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.
- Recall number
- Z-2402-2016
- Recalling firm
- Invacare Corporation
- 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.
- Status
- Terminated
- Initiated
- 2016-03-15
- Posted
- not on file
- Terminated
- 2017-09-15
- Reason
- 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.
- Root cause
- 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
- 1,011 units
- Distribution
- US Nationwide Distribution including DC and PR. Internationally Canada.
- Lot, serial or model codes
- Model #'s:1104343 & 1104345
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 1525712
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28