Hearth Record

Liberty Select Cycler

Medical device recall Z-0619-2024. Published in FDA’s Enforcement Report on Jan 3, 2024.

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 Jan 3, 2024. 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 III, the least serious of FDA’s three classes.

“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”

openFDA, in plain words, its enforcement report fields.

“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”

FDA’s rule, 21 CFR 7.3(m)(3), eCFR.

Source:

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

What’s wrong with it?

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

Source:

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

Which ones are recalled?

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

149 US, in FDA’s words.

Source:

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

Codes to check against yours

UDI-DI 00840861102068 Serial Numbers LC002956 LC102178 LC021724 LC107205 LC023197 LC021734 LC017434 LC108957 LC022069 LC103031 LC006834 LC022218 LC017378 LC026229 LC022262 LC104084 LC005140 LC022616 LC019115 LC021388 LC024210 LC108220…

Every code shown here, 1,377 characters

UDI-DI 00840861102068 Serial Numbers LC002956 LC102178 LC021724 LC107205 LC023197 LC021734 LC017434 LC108957 LC022069 LC103031 LC006834 LC022218 LC017378 LC026229 LC022262 LC104084 LC005140 LC022616 LC019115 LC021388 LC024210 LC108220 LC020906 LC024377 LC023711 LC121383 LC025541 LC118552 LC010607 LC025545 LC015082 LC111682 LC026353 LC114222 LC105047 LC102656 LC113355 LC104022 LC103069 LC115736 LC109288 LC104268 LC016965 LC121349 LC104371 LC105964 LC003341 LC104630 LC016669 LC113929 LC105108 LC020357 LC111447 LC105656 LC003460 LC112030 LC105951 LC107408 LC025450 LC106453 LC109867 LC012490 LC107813 LC108319 LC106079 LC108527 LC106667 LC122086 LC108652 LC110922 LC119859 LC108929 LC022708 LC010574 LC108988 LC113343 LC118563 LC109815 LC000539 LC105216 LC110210 LC108637 LC103326 LC112490 LC103658 LC104946 LC112954 LC024150 LC017621 LC113920 LC017046 LC017185 LC114230 LC022051 LC010500 LC117266 LC001887 LC002982 LC117324 LC102332 LC106468 LC117470 LC007590 LC100108 LC118836 LC016220 LC101309 LC120508 LC018125 LC010096 LC121590 LC022514 LC018533 LC121788 LC009410 LC002257 LC122822 LC105569 LC002521 LC116979 LC004607 LC006643 LC004836 LC109482 LC008971 LC115908 LC009077 LC123137 LC010282 LC102959 LC010363 LC020163 LC011334 LC107982 LC013964 LC118817 LC015496 LC118029 LC015554 LC119978 LC017329 LC104633 LC017436 LC020459 LC019811 LC110544 LC020468 LC113118 LC021140

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 in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.

The states and territories these words name

20 states and territories.

Every one of them
  • Alabama
  • California
  • Florida
  • Illinois
  • Indiana
  • Louisiana
  • Michigan
  • Missouri
  • Montana
  • North Carolina
  • New Jersey
  • Nevada
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • South Carolina
  • Tennessee
  • Texas
  • Virginia

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.

Source:

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

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, 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 Oct 24, 2023.
  • FDA classified it on Dec 26, 2023.
  • FDA’s Enforcement Report published it on Jan 3, 2024.
Source:

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

Who is recalling it?

  • Fresenius Medical Care Holdings, Inc., of Waltham, MA.
  • 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.”
  • 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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