Invacare Corporation
FDA Regulatory Profile
Invacare Corporation appears in FDA public data with 37 recalls, 20 510(k) clearances, 34 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1251-2024, Class II) was initiated on January 22, 2024. Its most recent 510(k) clearance was granted on April 12, 2021.
Summary
- Total Recalls
- 37
- 510(k) Clearances
- 20
- Inspections
- 34
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1251-2024 | Class II | Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G | January 22, 2024 |
| Z-2445-2023 | Class II | DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. | June 15, 2023 |
| Z-1369-2022 | Class III | Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) | June 10, 2022 |
| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V | March 30, 2022 |
| Z-0447-2022 | Class II | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY | November 12, 2021 |
| Z-0446-2022 | Class II | Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A | November 12, 2021 |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A a | November 12, 2021 |
| Z-0514-2021 | Class II | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring | October 30, 2020 |
| Z-0549-2019 | Class II | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a | November 16, 2018 |
| Z-2218-2017 | Class II | Assist Bed Rail - 6632 | April 25, 2017 |
| Z-1184-2017 | Class II | Foot Section - BAR5490IVC | December 2, 2016 |
| Z-1183-2017 | Class II | Bariatric Bed - BARPKG-IVC 1633 | December 2, 2016 |
| Z-1185-2017 | Class II | Junction Box - 1104343 and 1193560 | December 2, 2016 |
| Z-1182-2017 | Class II | Bariatric Bed - BAR600IVC | December 2, 2016 |
| Z-2365-2016 | Class II | Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvaca | June 21, 2016 |
| Z-2364-2016 | Class II | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare | June 21, 2016 |
| Z-2401-2016 | Class II | Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invaca | March 15, 2016 |
| Z-2399-2016 | Class II | Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Baria | March 15, 2016 |
| Z-2400-2016 | Class II | Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare B | March 15, 2016 |
| Z-2402-2016 | Class II | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a re | March 15, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | April 12, 2021 |
| K202379 | Invacare AVIVA Storm RX Power Chair | March 19, 2021 |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | August 6, 2020 |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | January 2, 2020 |
| K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, | August 29, 2019 |
| K182946 | Invacare TDX SP2-HD with Captain's Seat | December 11, 2018 |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | November 14, 2018 |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base fo | July 12, 2017 |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | April 17, 2017 |
| K162692 | Kuschall K-Series Attract Manual Wheelchair | December 28, 2016 |
| K162686 | Kuschall Champion Manual Wheelchair | December 28, 2016 |
| K162696 | Kuschall Advance Manual Wheelchair | December 28, 2016 |
| K160630 | Invacare Platinum Mobile Oxygen Concentrator | September 27, 2016 |
| K152536 | MyOn HC Manual Wheelchair | January 5, 2016 |
| K141783 | TDX SP2 POWER WHEECHAIR | January 9, 2015 |
| K083751 | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 | May 21, 2009 |
| K073134 | A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I | November 16, 2007 |
| K060582 | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR | March 16, 2006 |
| K042483 | INVACARE PRO, COMPACT AND PORTABLE DESKTOP | January 6, 2005 |
| K041072 | KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT | May 12, 2004 |