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Sign in to claim this brandInvacare GmbH
Germany·DE-MF-000006985
Last updated September 17, 2026
Information
- Country
- Germany
- Address
- 8, Am Achener Hof, Isny im Allgäu, Germany
- Website
- www.invacare.de
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Isabel Carqueija
- EUDAMED SRN
- DE-MF-000006985
- FDA FEI Number
- 3007231105
- DUNS Number
- —
Catalogue (124)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aviva RX10 | PL 1166 | EUDAMED | Class I | Active |
| Orca | 1571773 | EUDAMED | Class I | Active |
| Ocean Dual VIP Ergo | 1640487 | EUDAMED | Class I | Active |
| Orca | 1573864 | EUDAMED | Class I | Active |
| Orca | 1574459 | EUDAMED | Class I | Active |
| Revato | R7765/70WHITE | EUDAMED | Class I | Active |
| Pico | 9.20.001 | EUDAMED | Class I | Active |
| Revato | R7780/90WHITE | EUDAMED | Class I | Active |
| Disk on Dot grey | 1575268 | EUDAMED | Class I | Active |
| Revato | R7762/100W | EUDAMED | Class I | Active |
| Aviva RX10 | PL 1166 | EUDAMED | Class I | Active |
| Revato | R7769/80WHITE | EUDAMED | Class I | Active |
| Aviva RX20 | PL 1159 | EUDAMED | Class I | Active |
| Sorrento Bathtub swivel seat | 1532693 | EUDAMED | Class I | Active |
| Aviva Rx 40 Ulm | PL 1161 | EUDAMED | Class I | Active |
| Orca | 1573863 | EUDAMED | Class I | Active |
| Aviva RX10 | PL 1166 | EUDAMED | Class I | Active |
| Revato | R7773/80WHITE | EUDAMED | Class I | Active |
| Ocean Dual VIP Ergo | 1604134 | EUDAMEDFDA UDI | Class I | Active |
| 90000 | 8.31.101 | EUDAMED | Class I | Active |
| Revato | R7769/70WHITE | EUDAMED | Class I | Active |
| Sansibar | 9.10.101 | EUDAMED | Class I | Active |
| Adeo C407A | C407A | EUDAMED | Class I | Active |
| Stileo H172 | 1546226 | EUDAMED | Class I | Active |
| Pure Azure | 1654643 | EUDAMED | Class I | Active |
| Ocean Dual VIP Ergo | 1640561 | EUDAMED | Class I | Active |
| Cadiz H296 | 1637296 | EUDAMED | Class I | Active |
| I-Fit 9780E | 9780E | EUDAMED | Class I | Active |
| Revato | R7762/90WHITE | EUDAMED | Class I | Active |
| Disk | 4.02.008 | EUDAMED | Class I | Active |
| Revato | R7772/100WHITE | EUDAMED | Class I | Active |
| Pure Siro | 1654343 | EUDAMED | Class I | Active |
| Ocean Ergo | 1604208 | EUDAMED | Class I | Active |
| Revato | R7764/60WHITE | EUDAMED | Class I | Active |
| Omega H450 Classic | 1471163 | EUDAMED | Class I | Active |
| Revato | R7773/100WHITE | EUDAMED | Class I | Active |
| 90 Ergo | 1648581 | EUDAMED | Class I | Active |
| Dot | 1564679 | EUDAMED | Class I | Active |
| Ocean Ergo XL | 1604210 | EUDAMED | Class I | Active |
| Marina H112, pack of 5 | 1541330 | EUDAMED | Class I | Active |
| Omega H407 | 1471010 | EUDAMED | Class I | Active |
| Pure Sol | 1654265 | EUDAMED | Class I | Active |
| TDX SP2 ULM Narrow base | PL 1483 | EUDAMED | Class I | Active |
| Stileo H171 | 1546225 | EUDAMED | Class I | Active |
| Revato | R7769/90WHITE | EUDAMED | Class I | Active |
| Omega H440 Eco | 1563013 | EUDAMED | Class I | Active |
| Lima H273 | 1525733 | EUDAMED | Class I | Active |
| Cadiz H291 | 1637295 | EUDAMED | Class I | Active |
| Revato | R7772/80WHITE | EUDAMED | Class I | Active |
| Orca | 1573862 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 22, 2024 | Z-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, 2023 | Z-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, 2022 | Z-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, 2022 | Z-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, 2021 | Z-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, 2021 | Z-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, 2021 | Z-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, 2020 | Z-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, 2018 | Z-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, 2017 | Z-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, 2016 | Z-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, 2016 | Z-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, 2016 | Z-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, 2016 | Z-1182-2017 | — | terminated | The junction box used in the bariatric bed may emit sparks and result in a fire. |
| Jun 21, 2016 | Z-2364-2016 | — | terminated | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| Jun 21, 2016 | Z-2365-2016 | — | terminated | The rear gradation scale was screen printed upside down on the flowmeter gauge. |
| Mar 15, 2016 | Z-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, 2016 | Z-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, 2016 | Z-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, 2016 | Z-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, 2015 | Z-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, 2015 | Z-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, 2015 | Z-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, 2015 | Z-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, 2014 | Z-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, 2014 | Z-0872-2015 | — | terminated | The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. |
| Sep 23, 2014 | Z-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, 2014 | Z-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, 2014 | Z-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, 2013 | Z-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, 2013 | Z-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, 2013 | Z-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, 2012 | Z-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, 2012 | Z-0785-2013 | — | terminated | The potential exists for the wheel to rotate freely despite engagement of hub brake. |
| Aug 6, 2012 | Z-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, 2012 | Z-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, 2012 | Z-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, 2012 | Z-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, 2012 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2011 | Z-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, 2009 | Z-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, 2009 | Z-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, 2007 | Z-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, 2007 | Z-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, 2007 | Z-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, 2007 | Z-0966-2007 | — | terminated | Software error may permit the chair to recline too far. |
| Oct 16, 2006 | Z-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, 2006 | Z-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, 2006 | Z-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, 2006 | Z-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, 2006 | Z-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, 2006 | Z-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, 2006 | Z-1400-06 | — | terminated | Some of the wheelchairs were distributed with seats that did not have a seat positioning strap. |
| Oct 11, 2005 | Z-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, 2005 | Z-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, 2005 | Z-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, 2005 | Z-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, 2004 | Z-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, 2003 | Z-0344-04 | — | terminated | The weld joints on the seat back may fail and cause possible injury to the patient. |
| Dec 15, 2003 | Z-0343-04 | — | terminated | The weld joints on the seat back may fail and cause possible injury to the patient. |
| Dec 15, 2003 | Z-0342-04 | — | terminated | The weld joints on the seat back may fail and cause possible injury to the patient. |
| Mar 10, 2003 | Z-0682-03 | — | terminated | A short circuit within the charger harness may cause heat damage to the units with potential for fire. |
| Feb 10, 2003 | Z-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