Hearth Record

Junction Box - 1104343 and 1193560

Medical device recall Z-1185-2017. Published in FDA’s Enforcement Report on Feb 15, 2017.

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 Feb 15, 2017. 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?

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

Source:

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

Which ones are recalled?

Junction Box - 1104343 and 1193560

161 units, in FDA’s words.

Source:

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

Codes to check against yours

16FF017240 16EF024702 16EF024703 16EF022151 16EF022152 16EF022153 16EF023728 16FF017238 16FF017239 16EF024693 16EF024694 16FF019751 16EF014948 16EF018634 16EF018635 16EF018636 16FF017229 16FF017230 16EF022150 16EF032147 16EF032148…

Every code shown here, 1,991 characters

16FF017240 16EF024702 16EF024703 16EF022151 16EF022152 16EF022153 16EF023728 16FF017238 16FF017239 16EF024693 16EF024694 16FF019751 16EF014948 16EF018634 16EF018635 16EF018636 16FF017229 16FF017230 16EF022150 16EF032147 16EF032148 16EF032149 16EF032150 16EF032151 16EF032152 16FF015954 16FF015955 16FF015956 16FF015957 16EF018630 16EF018631 16EF034256 16EF022146 16EF022147 16EF018623 16FF017236 16EF032132 16EF027693 16EF027694 16EF029506 16EF027688 16EF027692 16EF029504 16EF024695 16FF019752 16FF019753 16EF029516 16EF029517 16EF029518 16EF029519 16EF014963 16EF024698 16EF024700 16EF024701 16FF022168 16EF016093 16EF023719 16FF022161 16FF022165 16EF024708 16FF017237 16EF027705 16EF023726 16EF014950 16EF014952 16EF011961 16EF011962 16EF011963 16EF011964 16EF014951 16EF018625 16EF018626 16EF018627 16EF018628 16EF018629 16EF022135 16EF022136 16EF022137 16EF022138 16EF022139 16FF015963 16FF015964 16FF015965 16FF015966 16FF019758 16FF019759 16FF019760 16FF019761 16FF019763 16FF019764 16FF019765 16FF019766 16FF019767 16EF023717 16EF024699 16FF022160 16EF024696 16FF022162 16FF022163 16EF022145 16EF029507 16FF017225 16EF029512 16FF017226 16EF016096 16EF016097 16EF016098 16EF029514 16EF027702 16EF016092 16EF016094 16EF016095 16EF032133 16EF037739 16EF027701 16EF027706 16EF029499 16EF032146 16EF016099 16EF016100 16EF022148 16EF022149 16EF027696 16EF034259 16EF034261 16FF019756 16EF032144 16EF029503 16EF029505 16EF029515 16FF024689 16FF024690 16EF018637 16EF018638 16EF018639 16EF018640 16EF018641 16EF018642 16EF027703 16EF027704 16EF029500 16EF029501 16EF032141 16EF032140 16EF032135 16EF037736 16EF023729 16EF023727 16FF017233 16FF017234 16EF029508 16EF029509 16FF017235 16EF018632 16EF034253 16EF034254 16EF032136 16EF032137 16EF032138 16EF032139 16EF024697 16EF027698 16EF022154 16EF027695 16EF032134 16EF024689 16EF023724 16FF022166 16FF022167 16EF018633 16EF024691 16EF024692 16FF019757 16EF027700 16FF015958 16FF015959 16FF015960 16FF015961 16FF015962 16EF022134 16EF016104…

FDA’s list runs to 2,749 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.

Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts

The states and territories these words name

37 states and territories.

Every one of them
  • Alaska
  • Alabama
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Florida
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • North Carolina
  • New Jersey
  • New Mexico
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
Source:

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

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 Dec 2, 2016.
  • FDA classified it on Feb 9, 2017.
  • FDA’s Enforcement Report published it on Feb 15, 2017.
  • FDA terminated it on Nov 2, 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 2,749 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.

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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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