Invacare Corporation
Invacare Corporation holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2021, with 37 FDA device recalls on record.
Top product codes for Invacare Corporation
FDA recalls by Invacare Corporation
10 most recent of 37- Z-1251-2024 — 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
- Z-2445-2023 — DOLOMITE 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 ROLLATOR
- Z-1369-2022 — Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
- Z-1130-2022 — Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
- Z-0445-2022 — Invacare 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-MCG
- Z-0446-2022 — Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
- Z-0447-2022 — Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
- Z-0514-2021 — Invacare 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, IRC5PO2VAWL5
- Z-0549-2019 — Invacare 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.
- Z-2218-2017 — Assist Bed Rail - 6632
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Invacare Corporation
- K203210 — Invacare Platinum 5NXG Oxygen Concentrator
- K202379 — Invacare AVIVA Storm RX Power Chair
- K200890 — Invacare Perfecto2V Oxygen Concentrator
- K192216 — Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
- K191159 — Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
- K182946 — Invacare TDX SP2-HD with Captain's Seat
- K181090 — Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
- K170507 — Invacare® TDX® SP2 Power Wheelchair +1 more
- K162621 — Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair
- K162686 — Kuschall Champion Manual Wheelchair
- K162692 — Kuschall K-Series Attract Manual Wheelchair
- K162696 — Kuschall Advance Manual Wheelchair
- K160630 — Invacare Platinum Mobile Oxygen Concentrator
- K152536 — MyOn HC Manual Wheelchair
- K141783 — TDX SP2 POWER WHEECHAIR
- K083751 — INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
- K073134 — A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
- K060582 — INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
- K042483 — INVACARE PRO, COMPACT AND PORTABLE DESKTOP
- K041072 — KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
Data sourced from openFDA. This site is unofficial and independent of the FDA.