Recall Register

Invacare Corporation: FDA recalls

FDA enforcement reports name Invacare Corporation as the recalling firm in 26 events. The events have 37 product records. The recalls started from 2012 to 2024. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

26 events, newest first.

FDA enforcement events of Invacare Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
22 Jan 2024Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOWDeviceClass II1Ongoing
15 Jun 2023DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATORDeviceClass II1Ongoing
10 Jun 2022Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)DeviceClass III1Ongoing
30 Mar 2022Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2VDeviceClass II1Ongoing
12 Nov 2021Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCGDeviceClass II3Ongoing
30 Oct 2020Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5DeviceClass II1Terminated
16 Nov 2018Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient.DeviceClass II1Terminated
25 Apr 2017Assist Bed Rail - 6632DeviceClass II1Terminated
2 Dec 2016Bariatric Bed - BAR600IVCDeviceClass II4Terminated
21 Jun 2016lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The…DeviceClass II2Terminated
15 Mar 2016Invacare 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.DeviceClass II4Terminated
2 Feb 2015Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.DeviceClass II1Terminated
15 Jan 2015TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.DeviceClass II3Terminated
5 Dec 2014G- Series Beds; G29 full length bed rails assemblyDeviceClass II1Terminated
31 Oct 2014Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.DeviceClass II1Terminated
23 Sep 2014Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from…DeviceClass II1Terminated
25 Jun 2014Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.DeviceClass II1Terminated
24 Jun 2014MK5 NX Controller--Wheelchair controllerDeviceClass II1Terminated
31 Aug 2013Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting functionDeviceClass II1Terminated
18 Jun 2013CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.DeviceClass II1Terminated
4 Jun 2013Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.DeviceClass II1Terminated
6 Nov 2012Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.DeviceClass II1Terminated
10 Sep 2012Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.DeviceClass II1Terminated
6 Aug 2012Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.DeviceClass II1Terminated
16 Apr 2012Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.DeviceClass II1Terminated
6 Apr 2012TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX,…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Invacare Corporation: events for each product type
TypeEvents
Device26
Invacare Corporation: events in each class
ClassEvents
Class II25
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
5

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Invacare Corporation, by the year that the recall started. The largest year is 2012, with 5 events.

Official channels

Cite this page

Recall Register. Invacare Corporation: FDA recalls. https://recallregister.com/firm/invacare-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
OH

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Invacare Corporation have?
Class II: 25 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Invacare Corporation?
FDA event 93875, which the firm started on 22 Jan 2024. The first product in the record is: Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
How many FDA recalls of Invacare Corporation have the status Ongoing?
5 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.