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OSIClass 2

Bariatric Bed

FDA adverse event reports and recall history for bariatric bed (product code OSI), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
1,296
Deaths
13
Injuries
88
Malfunctions
1,184

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20122026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2025-12-11Open, ClassifiedRelease of Material/Component prior to receiving test results

    Stryker MV3 bariatric bed, Part Number 5900000001

    Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker.

  • 2014-05-19TerminatedNonconforming Material/Component

    JK Bariatric Beds, True Air Technologies, Inc.

    The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

  • 2014-05-19TerminatedNonconforming Material/Component

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

  • 2013-06-05TerminatedDevice Design

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.

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