thejoe Invacare Corporation

Invacare Corporation: 37 FDA recall reports

Every medical device recall the FDA has published for Invacare Corporation. The fault, and how the agency graded it.

37Reports

0Class I

7Ongoing

2024-03-13Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	36
Class III	1

By year reported

Year	Reports
2012	3
2013	4
2014	5
2015	5
2016	6
2017	5
2018	1
2020	1
2022	5
2023	1
2024	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G5

Z-1251-2024 · Class II · reported 2024-03-13 · Ongoing

Why it was recalled: Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
Product: 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
Where it went: US Nationwide distribution.
How much: 8,117 units

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Num

Z-2445-2023 · Class II · reported 2023-08-30 · Ongoing

Why it was recalled: 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
Product: 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
Where it went: US Nationwide distribution.
How much: 586 devices

Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

Z-1369-2022 · Class III · reported 2022-07-20 · Ongoing

Why it was recalled: Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Product: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)
Where it went: Domestic distribution to the following states: ALASKA ARIZONA CALIFORNIA COLORADO GEORGIA IDAHO IOWA KANSAS KENTUCKY MICHIGAN MINNESOTA MISSOURI NEW YORK NORTH CAROLINA OHIO OKLAHOMA PENNSYLVANIA TENNESSEE
How much: 179 devices

Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

Z-1130-2022 · Class II · reported 2022-06-01 · Ongoing

Why it was recalled: 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.
Product: Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Where it went: Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada.
How much: 133 devices

Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-G

Z-0446-2022 · Class II · reported 2022-01-12 · Ongoing

Why it was recalled: 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
Product: 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
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
How much: 303 units US; 20 units OUS

Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY

Z-0445-2022 · Class II · reported 2022-01-12 · Ongoing

Why it was recalled: 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
Product: 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
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
How much: 1477 units US; 1226 units OUS

Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and

Z-0447-2022 · Class II · reported 2022-01-12 · Ongoing

Why it was recalled: 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
Product: 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
Where it went: Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
How much: 1 unit US

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemen

Z-0514-2021 · Class II · reported 2020-12-09 · Terminated

Why it was recalled: 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.
Product: 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
Where it went: Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands
How much: 384,767 units

Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Pow

Z-0549-2019 · Class II · reported 2018-12-12 · Terminated

Why it was recalled: 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.
Product: 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.
Where it went: Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
How much: 73,703 units

Assist Bed Rail - 6632

Z-2218-2017 · Class II · reported 2017-06-07 · Terminated

Why it was recalled: 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.
Product: Assist Bed Rail - 6632
Where it went: Product was shipped to all US states plus the District of Columbia. Product was also shipped to Canada and Australia.
How much: 5,020 Units

Bariatric Bed - BARPKG-IVC 1633

Z-1183-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
Product: Bariatric Bed - BARPKG-IVC 1633
Where it went: Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
How much: N/A

Junction Box - 1104343 and 1193560

Z-1185-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
Product: Junction Box - 1104343 and 1193560
Where it went: Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
How much: 161 units

Bariatric Bed - BAR600IVC

Z-1182-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: The junction box used in the bariatric bed may emit sparks and result in a fire.
Product: Bariatric Bed - BAR600IVC
Where it went: Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
How much: 411 Units

Foot Section - BAR5490IVC

Z-1184-2017 · Class II · reported 2017-02-15 · Terminated

Why it was recalled: A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
Product: Foot Section - BAR5490IVC
Where it went: Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
How much: 292 units

Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatr

Z-2401-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: 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.
Product: Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Where it went: US Nationwide Distribution including DC and PR. Internationally Canada.
How much: 3,050 units

Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric h

Z-2400-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: 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.
Product: Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Where it went: US Nationwide Distribution including DC and PR. Internationally Canada.
How much: 2,702 units

Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home

Z-2399-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: 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.
Product: Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Where it went: US Nationwide Distribution including DC and PR. Internationally Canada.
How much: 2,184 units

Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise

Z-2365-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: The rear gradation scale was screen printed upside down on the flowmeter gauge.
Product: Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Where it went: Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
How much: 395 units

lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx

Z-2364-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: The rear gradation scale was screen printed upside down on the flowmeter gauge.
Product: lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Where it went: Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
How much: 395

Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface

Z-2402-2016 · Class II · reported 2016-08-17 · Terminated

Why it was recalled: 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.
Product: Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Where it went: US Nationwide Distribution including DC and PR. Internationally Canada.
How much: 1,011 units

Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria

Z-2358-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: 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.
Product: Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
Where it went: Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO
How much: 1,057 finished devices

TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch wid

Z-1137-2015 · Class II · reported 2015-03-04 · Terminated

Why it was recalled: 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.
Product: TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Where it went: Worldwide Distribution-US (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada and Australia.
How much: 1942

FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch wid

Z-1138-2015 · Class II · reported 2015-03-04 · Terminated

Why it was recalled: 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.
Product: FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Where it went: Worldwide Distribution-US (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada and Australia.
How much: 60

Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24

Z-1139-2015 · Class II · reported 2015-03-04 · Terminated

Why it was recalled: 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.
Product: Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Where it went: Worldwide Distribution-US (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada and Australia.
How much: 525

G- Series Beds; G29 full length bed rails assembly

Z-1036-2015 · Class II · reported 2015-02-11 · Terminated

Why it was recalled: Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
Product: G- Series Beds; G29 full length bed rails assembly
Where it went: US Nationwide Distribution including OH, CO, MO, and NY.
How much: 2499 units

Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.

Z-0872-2015 · Class II · reported 2014-12-31 · Terminated

Why it was recalled: The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.
Product: Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
Where it went: The product was distributed throughout the U.S. and to foreign countries, including Canada and other countries TBD. The affected product was also distributed to eight government consignees.
How much: 138,446 units distributed globally

Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service pa

Z-0577-2015 · Class II · reported 2014-12-17 · Terminated

Why it was recalled: 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.
Product: Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
Where it went: Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
How much: 5,963

MK5 NX Controller--Wheelchair controller

Z-2091-2014 · Class II · reported 2014-07-30 · Terminated

Why it was recalled: 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.
Product: MK5 NX Controller--Wheelchair controller
Where it went: Nationwide Distriution: CA, SC, IL, UT, TN, KS, HI, NJ, LA, TX,FL, IN, AL, AZ, MN, WI, MN, MI, AR,MA, GA, MS, NJ, NM, OK, ME, PA, NY, NC, OK, MO, WA, IA, OR,KY, MD, NE, ID, VA, WA, ND, MT, OH, NH, CT. Also shipped to Canada
How much: 819

Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-V

Z-2023-2014 · Class II · reported 2014-07-16 · Terminated

Why it was recalled: 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.
Product: Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
Where it went: Distributed in PA and Canada.
How much: 465 units

Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by

Z-0634-2014 · Class II · reported 2014-01-15 · Terminated

Why it was recalled: The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
Product: Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
Where it went: US Distribution: Michigan only.
How much: 227 Wheelchairs

Showing the 30 most recent of 37. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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