Food, drugs, devices › Invacare Corporation

Device recall: Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is int

FDA enforcement event 73577 · Class II · initiated 15 Mar 2016 · status Terminated · terminated 15 Sep 2017

DeviceVoluntary: Firm initiated4 product recordsElyria, OH

Invacare Corporation (Elyria, OH) initiated this device recall on 15 Mar 2016; FDA lists 4 product records under event 73577, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 15 Sep 2017. Initiation: voluntary: firm initiated. Invacare Corporation has 26 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Invacare Corporation, Elyria, OH.

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."

Distribution

"US Nationwide Distribution including DC and PR. Internationally Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2399-2016	Invacare¿ Bariatric Bed w/o mattress & 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.	2,184 units	Class II	Terminated	17 Aug 2016
Z-2400-2016	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.	2,702 units	Class II	Terminated	17 Aug 2016
Z-2401-2016	Invacare¿ Foot Section for Semi & Full Electric Beds, 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.	3,050 units	Class II	Terminated	17 Aug 2016
Z-2402-2016	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.	1,011 units	Class II	Terminated	17 Aug 2016

Context

91%of 2016 device events are Class II1,232 events that year

4product records in this eventfirm median: 1

26events on this register for the firm

Other enforcement events for Invacare Corporation

Initiated	Product (first record)	Type	Class	Records
22 Jan 2024	Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4)	Device	Class II	1
15 Jun 2023	DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654	Device	Class II	1
10 Jun 2022	Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)	Device	Class III	1
30 Mar 2022	Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V	Device	Class II	1
12 Nov 2021	Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mod	Device	Class II	3
30 Oct 2020	Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen	Device	Class II	1
16 Nov 2018	Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient	Device	Class II	1
25 Apr 2017	Assist Bed Rail - 6632	Device	Class II	1
2 Dec 2016	Bariatric Bed - BAR600IVC	Device	Class II	4
21 Jun 2016	lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric	Device	Class II	2

All 26 events for Invacare Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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 materials."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution including DC and PR. Internationally Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Sep 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.