Z-2402-2016Class II

Junction Boxes

Name: Z-2402-2016 Junction Boxes
Creator: Invacare Corporation
Published: 2016-03-15
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2016-03-15 / Terminated / root cause: manufacturing process

FDA source

Invacare Corporation began a recall of Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable... on 2016-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2402-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2016-08-11
Terminated: 2017-09-15
Recalling firm: Invacare GmbH
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,011 units
Distribution: US Nationwide Distribution including DC and PR. Internationally Canada.
Product codes and lots: Model #'s:1104343 & 1104345

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2402-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2399-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2400-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2401-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11
Z-2402-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-11

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)