Invacare recalls
Invacare appears in 37 official U.S. recall notices indexed by RecallRadar, most recently on 2024-03-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 37 |
|---|---|
| Published | 2012-07-11 to 2024-03-13 |
| By agency | FDA Device (37) |
| By classification | Class II (36), Class III (1) |
| By status | terminated (30), ongoing (7) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5…
FDA Device · Class II · 2024-03-13 · Invacare
Reason: Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components - DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat
FDA Device · Class II · 2023-08-30 · Invacare
Reason: 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 - Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
FDA Device · Class III · 2022-07-20 · Invacare
Reason: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. - Invacare TDX SP2, Model Nos
FDA Device · Class II · 2022-06-01 · Invacare
Reason: 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 disconnect… - 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…
FDA Device · Class II · 2022-01-12 · Invacare
Reason: 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, res… - 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-…
FDA Device · Class II · 2022-01-12 · Invacare
Reason: 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, res… - Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP…
FDA Device · Class II · 2022-01-12 · Invacare
Reason: 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, res… - Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC…
FDA Device · Class II · 2020-12-09 · Invacare
Reason: 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 explosio… - 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…
FDA Device · Class II · 2018-12-12 · Invacare
Reason: 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 housin… - Assist Bed Rail - 6632
FDA Device · Class II · 2017-06-07 · Invacare
Reason: 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. - Bariatric Bed - BAR600IVC
FDA Device · Class II · 2017-02-15 · Invacare
Reason: The junction box used in the bariatric bed may emit sparks and result in a fire. - Bariatric Bed - BARPKG-IVC 1633
FDA Device · Class II · 2017-02-15 · Invacare
Reason: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. - Junction Box - 1104343 and 1193560
FDA Device · Class II · 2017-02-15 · Invacare
Reason: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. - Foot Section - BAR5490IVC
FDA Device · Class II · 2017-02-15 · Invacare
Reason: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. - Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton
FDA Device · Class II · 2016-08-17 · Invacare
Reason: The rear gradation scale was screen printed upside down on the flowmeter gauge. - Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provid…
FDA Device · Class II · 2016-08-17 · Invacare
Reason: 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 mate… - lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16
FDA Device · Class II · 2016-08-17 · Invacare
Reason: The rear gradation scale was screen printed upside down on the flowmeter gauge. - Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a…
FDA Device · Class II · 2016-08-17 · Invacare
Reason: 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 mate… - Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor…
FDA Device · Class II · 2016-08-17 · Invacare
Reason: 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 mate… - Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to pr…
FDA Device · Class II · 2016-08-17 · Invacare
Reason: 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 mate… - Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333…
FDA Device · Class II · 2015-08-19 · Invacare
Reason: 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 batte… - TDX Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare
Reason: 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… - Storm Series Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare
Reason: 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… - FDX Electric Wheelchair
FDA Device · Class II · 2015-03-04 · Invacare
Reason: 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… - G- Series Beds
FDA Device · Class II · 2015-02-11 · Invacare
Reason: Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety. - Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box
FDA Device · Class II · 2014-12-31 · Invacare
Reason: The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. - Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit
FDA Device · Class II · 2014-12-17 · Invacare
Reason: 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. - MK5 NX Controller--Wheelchair controller
FDA Device · Class II · 2014-07-30 · Invacare
Reason: 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… - Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family
FDA Device · Class II · 2014-07-16 · Invacare
Reason: 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. - Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity
FDA Device · Class II · 2014-01-15 · Invacare
Reason: The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled. - Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function
FDA Device · Class II · 2013-11-13 · Invacare
Reason: The 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 posit… - Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position
FDA Device · Class II · 2013-10-02 · Invacare
Reason: Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks. - CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person
FDA Device · Class II · 2013-08-28 · Invacare
Reason: There 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). - Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position
FDA Device · Class II · 2013-02-13 · Invacare
Reason: The potential exists for the wheel to rotate freely despite engagement of hub brake. - Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton
FDA Device · Class II · 2012-12-26 · Invacare
Reason: Following 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… - Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035
FDA Device · Class II · 2012-10-03 · Invacare
Reason: On 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. - TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair
FDA Device · Class II · 2012-07-11 · Invacare
Reason: Invacare 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 batt…