Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Invacare Bariatric Bed with mattress and rails , 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.

FDA Recall Z-2400-2016 · Posted None

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeFNL
Date Initiated2016-03-15
Date Terminated2017-09-15
Product Quantity2,702 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution including DC and PR. Internationally Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑