Food, drugs, devices › Invacare Corporation

Device recall: Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.

FDA enforcement event 68399 · Class II · initiated 25 Jun 2014 · status Terminated · terminated 15 Apr 2015

DeviceVoluntary: Firm initiated1 product recordElyria, OH

Invacare Corporation (Elyria, OH) initiated this device recall on 25 Jun 2014; FDA lists 1 product record under event 68399, 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 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 15 Apr 2015. 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 Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame."

Distribution

"Distributed in PA and Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2023-2014	Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.	465 units	Class II	Terminated	16 Jul 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record 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 Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame."

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: "Distributed in PA and Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Apr 2015. "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.