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Invacare Recalls

37 recalls on record · July 11, 2012 to March 13, 2024 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

March 13, 2024Medical DevicesFDA
Invacare Corporation recalls Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54
Hazard: Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
August 30, 2023Medical DevicesFDA
Invacare Corporation recalls DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1
Hazard: Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
July 20, 2022Medical DevicesFDA
Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Hazard: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
June 1, 2022Medical DevicesFDA
Invacare Corporation recalls Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Hazard: The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.
January 12, 2022Medical DevicesFDA
Invacare Corporation recalls Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101
Hazard: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
January 12, 2022Medical DevicesFDA
Invacare Corporation recalls Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Hazard: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
January 12, 2022Medical DevicesFDA
Invacare Corporation recalls Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mo
Hazard: Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
December 9, 2020Medical DevicesFDA
Invacare Corporation recalls Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen
Hazard: Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.
December 12, 2018Medical DevicesFDA
Invacare Corporation recalls Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patie
Hazard: Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause wear to the hardware and housings. If left unresolved, the caster may separate from the base of the lift causing the Lift to tilt and a patient fall. Failure does not occur right away but happens over time if the lift is not properly maintained. Patient falls are inherently dangerous and may result in a range of injuries that are dependent on physical condition of the patient and the nature of the fall. When injuries occur, they are typically non-serious injuries such as bruising, lacerations, or abrasions. In rare cases, more serious injuries such as bone fracture, head trauma, or death can occur. For caregivers using the lift, attempts to manually stabilize a lift if it becomes unstable could result in sprains, serious back injuries, or bone fractures.
June 7, 2017Medical DevicesFDA
Invacare Corporation recalls Assist Bed Rail - 6632
Hazard: A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.
February 15, 2017Medical DevicesFDA
Invacare Corporation recalls Junction Box - 1104343 and 1193560
Hazard: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
February 15, 2017Medical DevicesFDA
Invacare Corporation recalls Foot Section - BAR5490IVC
Hazard: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
February 15, 2017Medical DevicesFDA
Invacare Corporation recalls Bariatric Bed - BARPKG-IVC 1633
Hazard: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
February 15, 2017Medical DevicesFDA
Invacare Corporation recalls Bariatric Bed - BAR600IVC
Hazard: The junction box used in the bariatric bed may emit sparks and result in a fire.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adju
Hazard: 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.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home ca
Hazard: 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.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care b
Hazard: 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.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed i
Hazard: 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.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pedia
Hazard: The rear gradation scale was screen printed upside down on the flowmeter gauge.
August 17, 2016Medical DevicesFDA
Invacare Corporation recalls lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric
Hazard: The rear gradation scale was screen printed upside down on the flowmeter gauge.
August 19, 2015Medical DevicesFDA
Invacare Corporation recalls Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44
Hazard: The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.
March 4, 2015Medical DevicesFDA
Invacare Corporation recalls Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch widt
Hazard: If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
March 4, 2015Medical DevicesFDA
Invacare Corporation recalls FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configu
Hazard: If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
March 4, 2015Medical DevicesFDA
Invacare Corporation recalls TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configu
Hazard: If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
February 11, 2015Medical DevicesFDA
Invacare Corporation recalls G- Series Beds; G29 full length bed rails assembly
Hazard: Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
December 31, 2014Medical DevicesFDA
Invacare Corporation recalls Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Hazard: The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
December 17, 2014Medical DevicesFDA
Invacare Corporation recalls Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contain
Hazard: It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
July 30, 2014Medical DevicesFDA
Invacare Corporation recalls MK5 NX Controller--Wheelchair controller
Hazard: M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.
July 16, 2014Medical DevicesFDA
Invacare Corporation recalls Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Hazard: 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.
January 15, 2014Medical DevicesFDA
Invacare Corporation recalls Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare,
Hazard: The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
Invacare Recalls | RecallWatchUSA