CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
9805 and 9805P Hydraulic Patient Lifts recalled by Invacare
Invacare is recalling 9805 and 9805P Hydraulic Patient Lifts, distributed nationwide in the US. The recall was initiated on 16 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0549-2019
- FDA event ID
- 81071
- Recalling firm
- Invacare, Elyria, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2018
- FDA classified
- 3 Dec 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 16 Nov 2018 | Recall initiated by company | |
| 3 Dec 2018 | Classified by FDA | +17 days |
| 12 Dec 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 was distributed
Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
Questions about this recall
Why was it 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.
Which lots are affected?
Serial numbers ranging between 09FSZ590001 to 16ESZ104075. Specifically, serial numbers with the following starting values (see below). Each consignee will be receiving an impacted units list, which will include full serial numbers for the units that they have purchased: 10ASZ 11ASZ 12ASZ 13ASZ 14ASZ 15ASZ 16ASZ 10BSZ 11BSZ 12BSZ 13BSZ 14BSZ 15BSZ 16BSZ 10CSZ 11CSZ 12CSZ 13CSZ 14CSZ 15CSZ 16CSZ 10DSZ 11DSZ 12DSZ 13DSZ 14DSZ 15DSZ 16DSZ 10ESSZ 11ESSZ 12ESSZ 13ESSZ 14ESSZ 15ESSZ 16ESSZ 09FSZ 10FSZ 11FSZ 12FSZ 13FSZ 14FSZ 15FSZ 09GSZ 10GSZ 11GSZ 12GSZ 13GSZ 14GSZ 15GSZ 09HSZ 10HSZ 11HSZ 12HSZ 13HSZ 14HSZ 15HSZ 09ISZ 10ISZ 11ISZ 12ISZ 13ISZ 14ISZ 15ISZ 09JSZ 10JSZ 11JSZ 12JSZ 13JSZ 14JSZ 15JSZ 09KSZ 10KSZ 11KSZ 12KSZ 13KSZ 14KSZ 15KSZ 09LSZ 10LSZ 11LSZ 12LSZ 13LSZ 14LSZ 15LSZ
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Canada, Colombia, Germany, Guam, India, Northern Mariana Islands, Philippines and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Invacare
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dolomite Gloss Rollator - intended to support during recalled | Invacare | Foreign Material | Nationwide |
| Device | CLASS III | Platinum 5NXG Oxygen Concentrator recalled by Invacare | Invacare | Other | 18 states |
| Device | CLASS II | TDX SP2 recalled by Invacare | Invacare | Device Malfunction | Nationwide |
| Device | CLASS II | Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare | Invacare | Other | Nationwide |
| Device | CLASS II | TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled | Invacare | Other | Nationwide |
Other Wheelchairs, Beds & Lifts recalls
All 172| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |