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CriticalFDAfda-Z-0549-2019SERIOUS INJURY OR DEATH

Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lif...

⚠ Critical FDA Safety Notice — Talk to Your Doctor

The FDA has flagged this as a serious safety concern (serious injury or death). Do not stop, change, or discard a prescribed medication or medical device on your own. Contact your doctor or pharmacist immediately to ask whether this notice applies to your prescription and what to do next. Any specific guidance below comes directly from the FDA — Product Recall Tracker does not provide medical advice.

Units Affected
73,703
Recall Date
November 16, 2018
Issuing Agency
Hazard
Serious Injury Or Death

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0549-2019.

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.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0549-2019.

Recall terminated by FDA.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0549-2019.

Invacare Corporation

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

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Invacare Corporation Recall FAQ

Invacare Corporation is the subject of a medical devices safety report: Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lif.... The notice was published on November 16, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 73,703 units are potentially affected.