FREEDOM DESIGNS, INC.
26 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (26)
Devices registered here (1)
- Footrest, WheelchairProduct code IMM (opens in a new tab) · Class I · Physical Medicine · 21 CFR 890.3920
Recalls & enforcement
20241 record
- Class IIOngoing2024-01-22Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
20231 record
- Class IIOngoing2023-06-15Premature 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
20222 records
- Class IIIOngoing2022-06-10Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
- Class IIOngoing2022-03-30The 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 wh…
20211 record
- Class IIOngoing2021-11-12Power 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
20201 record
- Class IITerminated2020-10-30Breakdown 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.
20181 record
- Class IITerminated2018-11-16Invacare 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…
20171 record
- Class IITerminated2017-04-25A 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.
20163 records
- Class IITerminated2016-12-02A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
- Class IITerminated2016-06-21The rear gradation scale was screen printed upside down on the flowmeter gauge.
- Class IITerminated2016-03-15The 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.
20152 records
- Class IITerminated2015-02-02The 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.
- Class IITerminated2015-01-15If 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 sa…
20145 records
- Class IITerminated2014-12-05Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
- Class IITerminated2014-10-31The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
- Class IITerminated2014-09-23It 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.
- Class IITerminated2014-06-25The 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.
- Class IITerminated2014-06-24M41 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 …
20133 records
- Class IITerminated2013-08-31The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fi…
- Class IITerminated2013-06-18There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).
- Class IITerminated2013-06-04Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
20125 records
- Class IITerminated2012-11-06Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. The device was recalled from distribution based on reports indicating that there is a possibility that the button which holds the cane at the desired height, may sudd…
- Class IITerminated2012-09-10The potential exists for the wheel to rotate freely despite engagement of hub brake.
- Class IITerminated2012-08-06On August 6, 2012, Invacare voluntarily recalled the Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event data received.
- Class IITerminated2012-04-16The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
- Class IITerminated2012-04-06Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path aro…
Related
- All facilities operated by Invacare Corporation dba Invacare America
- INVAMEX S.DE R.L. DE C.V. (MX)
- ALBER GMBH (DE)
- INVACARE CORP. DBA INVACARE AMERICA (OH)
- Invacare Portugal, Lda (PT)
- Invacare GmbH (DE)
- Invacare UK Ltd. (GB)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “FREEDOM DESIGNS, INC. (FEI 2081283) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2081283-freedom-designs-inc/
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