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Invacare GmbH

Germany·DE-MF-000006985

Last updated September 17, 2026

Information

Country
Germany
Address
8, Am Achener Hof, Isny im Allgäu, Germany
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Isabel Carqueija
EUDAMED SRN
DE-MF-000006985
FDA FEI Number
3007231105
DUNS Number
—

Catalogue (124)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Aviva RX10 PL 1166
EUDAMED
Class IActive
Orca 1571773
EUDAMED
Class IActive
Ocean Dual VIP Ergo 1640487
EUDAMED
Class IActive
Orca 1573864
EUDAMED
Class IActive
Orca 1574459
EUDAMED
Class IActive
Revato R7765/70WHITE
EUDAMED
Class IActive
Pico 9.20.001
EUDAMED
Class IActive
Revato R7780/90WHITE
EUDAMED
Class IActive
Disk on Dot grey 1575268
EUDAMED
Class IActive
Revato R7762/100W
EUDAMED
Class IActive
Aviva RX10 PL 1166
EUDAMED
Class IActive
Revato R7769/80WHITE
EUDAMED
Class IActive
Aviva RX20 PL 1159
EUDAMED
Class IActive
Sorrento Bathtub swivel seat 1532693
EUDAMED
Class IActive
Aviva Rx 40 Ulm PL 1161
EUDAMED
Class IActive
Orca 1573863
EUDAMED
Class IActive
Aviva RX10 PL 1166
EUDAMED
Class IActive
Revato R7773/80WHITE
EUDAMED
Class IActive
Ocean Dual VIP Ergo 1604134
EUDAMEDFDA UDI
Class IActive
90000 8.31.101
EUDAMED
Class IActive
Revato R7769/70WHITE
EUDAMED
Class IActive
Sansibar 9.10.101
EUDAMED
Class IActive
Adeo C407A C407A
EUDAMED
Class IActive
Stileo H172 1546226
EUDAMED
Class IActive
Pure Azure 1654643
EUDAMED
Class IActive
Ocean Dual VIP Ergo 1640561
EUDAMED
Class IActive
Cadiz H296 1637296
EUDAMED
Class IActive
I-Fit 9780E 9780E
EUDAMED
Class IActive
Revato R7762/90WHITE
EUDAMED
Class IActive
Disk 4.02.008
EUDAMED
Class IActive
Revato R7772/100WHITE
EUDAMED
Class IActive
Pure Siro 1654343
EUDAMED
Class IActive
Ocean Ergo 1604208
EUDAMED
Class IActive
Revato R7764/60WHITE
EUDAMED
Class IActive
Omega H450 Classic 1471163
EUDAMED
Class IActive
Revato R7773/100WHITE
EUDAMED
Class IActive
90 Ergo 1648581
EUDAMED
Class IActive
Dot 1564679
EUDAMED
Class IActive
Ocean Ergo XL 1604210
EUDAMED
Class IActive
Marina H112, pack of 5 1541330
EUDAMED
Class IActive
Omega H407 1471010
EUDAMED
Class IActive
Pure Sol 1654265
EUDAMED
Class IActive
TDX SP2 ULM Narrow base PL 1483
EUDAMED
Class IActive
Stileo H171 1546225
EUDAMED
Class IActive
Revato R7769/90WHITE
EUDAMED
Class IActive
Omega H440 Eco 1563013
EUDAMED
Class IActive
Lima H273 1525733
EUDAMED
Class IActive
Cadiz H291 1637295
EUDAMED
Class IActive
Revato R7772/80WHITE
EUDAMED
Class IActive
Orca 1573862
EUDAMEDFDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (67)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jan 22, 2024Z-1251-2024—open, classified

Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

Jun 15, 2023Z-2445-2023—open, classified

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

Jun 10, 2022Z-1369-2022—open, classified

Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

Mar 30, 2022Z-1130-2022—open, classified

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.

Nov 12, 2021Z-0447-2022—open, classified

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

Nov 12, 2021Z-0446-2022—open, classified

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

Nov 12, 2021Z-0445-2022—open, classified

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

Oct 30, 2020Z-0514-2021—terminated

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.

Nov 16, 2018Z-0549-2019—terminated

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.

Apr 25, 2017Z-2218-2017—terminated

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.

Dec 2, 2016Z-1185-2017—terminated

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

Dec 2, 2016Z-1183-2017—terminated

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

Dec 2, 2016Z-1184-2017—terminated

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

Dec 2, 2016Z-1182-2017—terminated

The junction box used in the bariatric bed may emit sparks and result in a fire.

Jun 21, 2016Z-2364-2016—terminated

The rear gradation scale was screen printed upside down on the flowmeter gauge.

Jun 21, 2016Z-2365-2016—terminated

The rear gradation scale was screen printed upside down on the flowmeter gauge.

Mar 15, 2016Z-2401-2016—terminated

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.

Mar 15, 2016Z-2399-2016—terminated

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.

Mar 15, 2016Z-2400-2016—terminated

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.

Mar 15, 2016Z-2402-2016—terminated

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.

Feb 2, 2015Z-2358-2015—terminated

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.

Jan 15, 2015Z-1139-2015—terminated

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.

Jan 15, 2015Z-1137-2015—terminated

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.

Jan 15, 2015Z-1138-2015—terminated

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.

Dec 5, 2014Z-1036-2015—terminated

Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.

Oct 31, 2014Z-0872-2015—terminated

The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard.

Sep 23, 2014Z-0577-2015—terminated

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.

Jun 25, 2014Z-2023-2014—terminated

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.

Jun 24, 2014Z-2091-2014—terminated

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.

Aug 31, 2013Z-0167-2014—terminated

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 position and or tilted position. This may result in the snap-on fixture coming unlatched.

Jun 18, 2013Z-1980-2013—terminated

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).

Jun 4, 2013Z-2270-2013—terminated

Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

Nov 6, 2012Z-0556-2013—terminated

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 button which holds the cane at the desired height, may suddenly and unexpectedly compress, causing the cane to collapse and cause possible injury to the user.

Sep 10, 2012Z-0785-2013—terminated

The potential exists for the wheel to rotate freely despite engagement of hub brake.

Aug 6, 2012Z-2461-2012—terminated

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.

Apr 16, 2012Z-0634-2014—terminated

The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

Apr 6, 2012Z-1905-2012—terminated

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 battery bracket which would create an alternate current path around the fuse.

Apr 6, 2012Z-1704-2012—terminated

Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. As a result, the user may fall.

Feb 10, 2012Z-1201-2012—terminated

Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.

Dec 7, 2011Z-0774-2012—terminated

Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.

Jun 23, 2011Z-0187-2012—terminated

Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.

Apr 1, 2011Z-2741-2011—terminated

Component Defect. The rear mast connector on certain patient lifts distributed by the firm, may break. Failure of the rear mast connector, while in use would result in a patient being dropped, possibly resulting in serious injury or death to the patient or care provider.

Mar 2, 2011Z-3280-2011—terminated

The firm is conducting a recall/correction of their adult and junior wheeled walkers due to a component defect. The firm determined that the caster bolt on the wheeled extension was too short to adequately maintain the Nylex fastener. Consequently, over time, this condition incurs the potential for the caster to loosen and detach, causing the wheels to fall off the walker. This scenario would res

Jan 11, 2011Z-1423-2011—terminated

Invacare Corporation decided to recall the products because risk analysis reveals that inadequate clearance between a motor ground clip and the motor windings may result in an increased risk for shock to service personnel. It also may result in contact with the motor winding, resulting in a shorted winding; this condition has the potential to result in motor failure/shutdown or to cause the motor

Sep 15, 2009Z-0579-2010—terminated

For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for

Jun 15, 2009Z-0421-2010—terminated

The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).

Nov 27, 2007Z-0930-2009—terminated

Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.

Oct 11, 2007Z-2402-2010—terminated

In October 2007 Invacare Corporation, Florida recalled CareGuard Mattresses, Models CG10180 and CG10180A, associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Beds, when used with Invacare bed rails. Affected bed packages are BED24IVC, BED25IVC, BED24CA, and BED25CA. The mattresses when used in combination with the IVC a

Aug 29, 2007Z-2403-2010—terminated

In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric a

Mar 19, 2007Z-0966-2007—terminated

Software error may permit the chair to recline too far.

Oct 16, 2006Z-2393-2010—terminated

Invacare Corporation, Florida issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006.

Sep 27, 2006Z-0063-2007—terminated

The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).

Jul 18, 2006Z-1486-06—terminated

If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.

Jun 27, 2006Z-1510-06—terminated

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

Jun 27, 2006Z-1511-06—terminated

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

Jun 27, 2006Z-1509-06—terminated

The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut.

Jun 14, 2006Z-1400-06—terminated

Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.

Oct 11, 2005Z-0303-06—terminated

When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.

May 2, 2005Z-0903-05—terminated

If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.

May 2, 2005Z-0901-05—terminated

If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.

May 2, 2005Z-0902-05—terminated

If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.

Jul 23, 2004Z-0158-06—terminated

Component Defect. Metal Oxide Varister (MOV) component of the junction box may short circuit with the potential for device failure.

Dec 15, 2003Z-0344-04—terminated

The weld joints on the seat back may fail and cause possible injury to the patient.

Dec 15, 2003Z-0343-04—terminated

The weld joints on the seat back may fail and cause possible injury to the patient.

Dec 15, 2003Z-0342-04—terminated

The weld joints on the seat back may fail and cause possible injury to the patient.

Mar 10, 2003Z-0682-03—terminated

A short circuit within the charger harness may cause heat damage to the units with potential for fire.

Feb 10, 2003Z-0574-03—terminated

A short circuit within the charger harness may cause heat damage to the units with potential for fire.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Invacare Corp. US