Hearth Record

Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home…

Medical device recall Z-2400-2016. Published in FDA’s Enforcement Report on Aug 17, 2016.

FDA’s own record, on accessdata.fda.gov

No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.

The short answer

Published in FDA’s Enforcement Report on Aug 17, 2016. Copied from openFDA on Oct 20, 2026.

Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.

How serious is it, by FDA’s class?

Class II, the middle of FDA’s three classes.

“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”

openFDA, in plain words, its enforcement report fields.

“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

FDA’s rule, 21 CFR 7.3(m)(2), eCFR.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.

2,702 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Model #: BARPKGIVC-1633; Serial #s: 15BF015617 15BF015618 15IF040586 15LF007886 15LF030500 15IF044964 15JF027523 15DF039684 15IF000656 15JF039196 15LF025841 15GF013405 15IF001676 15IF003788 15IF028783 15IF028784 15JF010270 15JF014683…

Every code shown here, 1,994 characters

Model #: BARPKGIVC-1633; Serial #s: 15BF015617 15BF015618 15IF040586 15LF007886 15LF030500 15IF044964 15JF027523 15DF039684 15IF000656 15JF039196 15LF025841 15GF013405 15IF001676 15IF003788 15IF028783 15IF028784 15JF010270 15JF014683 15KF033384 16AF011108 15LF003819 16AF024508 16AF024509 15BF015622 15BF024675 15BF024678 15DF001324 15DF011345 15DF016457 15DF038243 15DF038244 15FF043818 15FF043822 15GF013418 15GF013419 15GF030895 15IF022355 15BF015626 15BF018543 15BF018544 15BF018545 15BF018546 15BF018547 15BF019841 15BF015624 15BF031157 15CF035105 15CF035106 15EF028981 15GF011720 15GF011721 15BF010327 15BF015640 15CF037855 15CF037856 15CF037857 15DF006120 15DF006121 15DF006122 15DF006123 15EF037541 15EF037542 15GF006873 15LF016357 15DF031032 15LF023497 16AF014286 16AF014287 15EF027547 15EF027552 15CF001424 15CF001425 15DF038252 15DF038253 15BF007598 15BF007599 15BF007600 15CF008156 15CF024415 15CF024416 15CF024417 15CF024418 15CF048563 15CF048564 15CF048565 15DF011352 15FF043823 15FF043826 15FF043827 15KF009783 15KF009784 15KF009785 15LF023499 15LF025846 16BF020108 16BF020109 16BF020110 16BF022580 16BF022581 16BF022582 15CF035118 15CF048566 15CF035123 15CF055440 15IF026984 15IF040587 15KF014079 15JF005606 15JF005607 16AF026276 15EF028976 15KF009791 15EF014829 15GF006890 15LF039839 15DF025056 15DF025057 15DF025058 15DF025059 15DF025060 15GF013370 15GF013371 15GF013372 15GF013373 15GF013374 15HF041628 15HF041629 15HF041630 15HF041631 15HF041632 15HF041633 15HF041634 15HF041635 15HF041636 15HF041637 15IF003770 15IF003771 15IF003772 15IF003773 15IF003774 15LF007897 15CF055423 15CF048577 15CF048578 15CF048579 15CF048580 15LF037329 16AF027999 15BF042550 15CF009491 15BF018527 15BF018528 15BF051617 15BF051618 15BF051619 15BF051620 15EF012112 15EF014821 15EF014822 15EF022750 15EF022751 15EF022752 15EF022753 15EF028971 15EF028972 15FF000654 15FF000655 15FF000656 15FF000657 15FF029239 15FF029240 15IF020125 15IF020126 15IF022351 15IF022352 15IF022353 15IF031668 15IF031669…

FDA’s list runs to 27,106 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Where did it go?

FDA’s words for the “general area of initial distribution”: where the firm first shipped it.

US Nationwide Distribution including DC and PR. Internationally Canada.

The states and territories these words name

  • District of Columbia
  • Puerto Rico

What FDA means by nationwide

“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”

openFDA, its enforcement report fields.

The words say it went outside the United States too.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Terminated, in FDA’s file.

“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”

openFDA, on “Terminated”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Mar 15, 2016.
  • FDA classified it on Aug 11, 2016.
  • FDA’s Enforcement Report published it on Aug 17, 2016.
  • FDA terminated it on Sep 15, 2017.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Invacare Corporation, of Elyria, OH.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

What this record can’t tell you

  • Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
  • Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
  • How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
  • Whether anyone was hurt or fell ill: the report doesn’t say.
  • How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
  • FDA’s list of codes runs to 27,106 characters; the first part is shown here, and the rest is on FDA’s record.
  • A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • U.S. Food and Drug Administration, Device recall enforcement reports.

    Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.

Source:

Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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