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Arjo, Inc.

Country not established

Devices
1
FDA recalls
31

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Arjo, Inc. makes

Arjo, Inc. manufactures recumbent bathing systems, including the Rhapsody and Primo models, designed for therapeutic bathing and mobility support in clinical or home settings.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls31

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 31 recalls initiated by Arjo, Inc., the earliest on 2003-01-30 and the most recent on 2008-12-08. By recorded status: 31 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 31 recalls.

  • 2008

    • 8 Dec 2008 Z-0933-2009 Unclassified (pre-2012) Terminated The manufacturer, BHM Medical, has received reports of structural failure of the mast during use. Distribution: Nationwide Distribution.
    • 5 Nov 2008 Z-0503-2009 Unclassified (pre-2012) Terminated The battery pack NDA0200-20, lot 070826D, sold with the Maxi Move patient lift or as replacement parts, has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission. Distribution: Nationwide Distribution
    • 30 Oct 2008 Z-0412-2009 Unclassified (pre-2012) Terminated If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment. Distribution: Nationwide Distribution.
    • 30 Oct 2008 Z-0413-2009 Unclassified (pre-2012) Terminated If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment. Distribution: Nationwide Distribution.
    • 20 Oct 2008 Z-0322-2009 Unclassified (pre-2012) Terminated The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling. Distribution: Nationwide Distribution.
    • 20 Oct 2008 Z-0323-2009 Unclassified (pre-2012) Terminated The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling. Distribution: Nationwide Distribution.
    • 8 Sep 2008 Z-2470-2008 Unclassified (pre-2012) Terminated There is the potential for unintended dislocation of the Lock and Load hanger assembly (Combi Hanger) from the t-bar attached to the lifter jib of the Maxi Move patient lift. Distribution: Nationwide Distribution
    • 1 Aug 2008 Z-2434-2008 Unclassified (pre-2012) Terminated There is a possibility that the Kwiktrak Gate System could malfunction, resulting in the gate locks opening even though the corresponding tracks are not properly aligned. Distribution: Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri,…
      Full distribution text Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, New York, North Carolina, Ohio, Oklahoma, Texas, and Wisconsin.
    • 5 May 2008 Z-1650-2008 Unclassified (pre-2012) Terminated The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries. Distribution: Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
    • 5 May 2008 Z-1651-2008 Unclassified (pre-2012) Terminated The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries. Distribution: Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
Show the 25 most recent of 31 recalls

  • 2008

    • 10 Apr 2008 Z-1557-2008 Unclassified (pre-2012) Terminated Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at the time, the patient could fall and sustain injuries. Distribution: Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio,…
      Full distribution text Nationwide Distribution --- including states of California, Florida, Illinois, Michigan, Minnesota, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Washington, and Wyoming.
    • 20 Feb 2008 Z-1233-2008 Unclassified (pre-2012) Terminated The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control. Distribution: Nationwide Distribution.

  • 2007

    • 19 Dec 2007 Z-1135-2008 Unclassified (pre-2012) Terminated Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall. Distribution: Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana,…
      Full distribution text Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin.
    • 19 Dec 2007 Z-1136-2008 Unclassified (pre-2012) Terminated Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall. Distribution: Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana,…
      Full distribution text Nationwide including the states of Alabama, Arizona, California, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin.
    • 15 Oct 2007 Z-0261-2008 Unclassified (pre-2012) Terminated Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position. Distribution: Nationwide
    • 23 Jan 2007 Z-1234-2008 Unclassified (pre-2012) Terminated Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor. Distribution: Nationwide Distribution --- including states of California, Connecticut, Florida, Mississippi and Texas.
    • 9 Jan 2007 Z-0424-2007 Unclassified (pre-2012) Terminated There is the potential for the slings to come apart, potentially allowing injury to the patient. Distribution: Nationwide
    • 9 Jan 2007 Z-0425-2007 Unclassified (pre-2012) Terminated There is the potential for the slings to come apart, potentially allowing injury to the patient. Distribution: Nationwide
    • 9 Jan 2007 Z-0426-2007 Unclassified (pre-2012) Terminated There is the potential for the slings to come apart, potentially allowing injury to the patient. Distribution: Nationwide
    • 5 Jan 2007 Z-0796-2007 Unclassified (pre-2012) Terminated The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place. Distribution: Nationwide
    • 5 Jan 2007 Z-0797-2007 Unclassified (pre-2012) Terminated The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place. Distribution: Nationwide
    • 5 Jan 2007 Z-0798-2007 Unclassified (pre-2012) Terminated The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place. Distribution: Nationwide
    • 5 Jan 2007 Z-0799-2007 Unclassified (pre-2012) Terminated The hanger bar assembly may detach from the Maxi Move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place. Distribution: Nationwide

  • 2006

    • 13 Nov 2006 Z-0482-2007 Unclassified (pre-2012) Terminated The carabineer may not be correctly attached to the reacher and the portable patient lift may drop. Distribution: Nationwide
    • 30 Oct 2006 Z-0248-2007 Unclassified (pre-2012) Terminated The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose. Distribution: Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and…
      Full distribution text Nationwide, including Florida, Illinois, Indiana, Iowa, Kansas, Massachusetts, New York, Tennessee, Virginia and Wyoming.

Frequently asked questions

How many devices does Arjo, Inc. have in the registry?

The registry currently lists 1 device for Arjo, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Arjo, Inc.'s devices?

Among its 1 most recently registered device, Arjo, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Arjo, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Arjo, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Arjo, Inc.?

FDA recall records list 31 recalls initiated by Arjo, Inc., the most recent initiated on 8 Dec 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Arjo, Inc. in the registry?

The most recently registered devices listed for Arjo, Inc. include RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO.

Generated automatically from registry data and not verified by a human reviewer.