Abbott Liberta RC, Implantable Pulse Generator
Medical device recall Z-2265-2024. Published in FDA’s Enforcement Report on Jul 10, 2024.
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 Jul 10, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 32 states named
- 302 units how much, in FDA’s words
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
302 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 05415067047663/ Serial Numbers: 20196493 20196495 20196496 20196497 20196498 20196500 20196502 20196503 20196504 20196505 20196506 20196507 20196508 20196509 20196511 20196512 20196513 20196514 20196515 20196516 20196517 20207397…
Every code shown here, 1,993 characters
UDI-DI: 05415067047663/ Serial Numbers: 20196493 20196495 20196496 20196497 20196498 20196500 20196502 20196503 20196504 20196505 20196506 20196507 20196508 20196509 20196511 20196512 20196513 20196514 20196515 20196516 20196517 20207397 20207398 20207399 20207400 20207401 20207402 20207403 20207404 20207406 20207407 20207408 20207409 20207410 20207411 20207412 20207413 20207416 20207417 20207419 20207420 20207421 20207422 20207423 20207424 20207425 20207427 20207428 20207429 20207430 20207431 20207432 20207433 20207434 20207435 20207436 20207437 20207438 20207441 20207442 20207443 20207445 20207447 20207448 20207449 20207450 20207451 20207452 20207454 20207455 20207456 20207457 20207458 20207459 20207460 20207461 20207462 20207463 20207465 20207466 20207468 20207469 20207470 20207471 20207473 20207474 20207477 20207478 20207481 20207482 20207483 20207484 20207485 20207486 20207487 20207488 20207489 20207490 20207491 20207494 20207495 20208681 20208682 20208683 20208685 20208687 20208688 20208689 20208690 20208691 20208692 20208693 20208696 20208697 20208698 20208699 20208701 20208703 20208704 20219079 20219080 20219081 20219082 20219083 20219084 20219087 20219088 20219089 20219090 20219092 20219093 20219095 20219096 20219099 20219100 20219101 20219102 20219103 20219104 20219105 20219106 20219107 20219108 20219111 20219114 20219115 20219116 20219117 20219118 20219119 20219120 20219121 20219122 20219123 20219126 20219128 20219129 20219130 20219131 20219132 20219133 20219134 20219135 20219136 20219139 20219140 20219142 20219144 20219145 20219146 20219147 20219148 20219149 20219151 20219152 20219154 20219155 20219156 20219157 20219159 20219160 20219162 20219163 20219166 20219167 20219169 20219171 20219174 20219176 20219178 20232812 20232815 20232816 20232818 20232819 20232820 20232821 20232822 20232823 20232824 20232827 20232829 20232831 20232832 20232833 20232834 20232836 20232837 20232839 20232844 20232846 20232849 20232850 20232851 20232852 20232854 20232855…
FDA’s list runs to 2,757 characters. The first part is shown; the rest is on FDA’s record.
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 in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI, WV.
The states and territories these words name
32 states and territories.
Every one of them
- Arizona
- California
- Colorado
- District of Columbia
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- Nebraska
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Texas
- Utah
- Wisconsin
- West 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.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 16, 2024.
- FDA classified it on Jul 3, 2024.
- FDA’s Enforcement Report published it on Jul 10, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Medical, of Plano, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 2,757 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.