Unify, Sterile EO
Medical device recall Z-2326-2018. Published in FDA’s Enforcement Report on Jul 4, 2018.
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 4, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 40738 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?
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
40738, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1015752 730063 739101 737664 1100971 1220399 1220292 1220290 1220402 1220289 1220397 1220296 790402 1220298 1220297 1220302 1220398 1220300 1220304 1011008 1045234 727133 727125 1015722 769238 782698 806935 1203620 824778 1194681…
Every code shown here, 1,994 characters
Serial #: 1015752 730063 739101 737664 1100971 1220399 1220292 1220290 1220402 1220289 1220397 1220296 790402 1220298 1220297 1220302 1220398 1220300 1220304 1011008 1045234 727133 727125 1015722 769238 782698 806935 1203620 824778 1194681 1194692 1142920 1142348 1142916 761491 763173 768968 746500 773404 790396 807191 805967 761487 769242 749537 761680 720899 788660 769286 782672 761268 784460 825005 717555 736459 810157 805939 815815 824979 790367 725376 740816 816153 805857 761277 810470 761544 795775 787617 810502 782965 782595 716018 810139 795160 714115 763261 759507 760107 756103 761270 746528 751518 759307 752216 729982 739033 746540 784581 739855 733125 715856 746556 721983 810191 782611 1045235 784269 720881 717536 720903 769225 810648 1193445 810477 768943 714157 815756 715461 1043121 720930 715656 1000812 714194 1043232 815769 1047169 769275 810506 782683 1000878 1131834 1002830 806928 745695 1010975 1002659 789012 1131844 769260 807177 745697 752813 747715 745628 751735 746480 752547 752508 746561 747776 747741 746497 746536 747683 746517 751684 747728 749993 746479 745682 747766 751728 746537 745710 746509 745671 743847 747746 745676 745644 745670 743912 745677 749872 745488 795229 745685 750012 745463 747716 749452 745469 745658 745484 745662 745675 745512 745627 749790 745652 745478 763214 745648 749995 747758 749801 750058 750040 749457 747753 749505 752824 750052 749448 750043 749529 750082 745432 749517 749488 749441 749467 749498 747679 750063 750073 749878 747747 750080 749837 750075 750005 750032 806791 749846 749873 749775 750053 749877 749447 749802 749494 747689 749540 749838 749807 750084 749831 745614 749472 749773 750074 747771 749470 750048 749533 749535 749440 749820 750079 749456 750067 749445 749478 749780 749832 747712 749823 745707 746531 749429 745477 745508 752530 749849 747711 745495 749507 745637 749490 747682 749542 750039 745683 745688 747704 745511 1002829 749491 746483 745709 1017808 749767 750034 752212 750023 747690…
FDA’s list runs to 331,357 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.
U.S. Nationwide distribution
These words name no state.
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?
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 16, 2018.
- FDA classified it on Jun 28, 2018.
- FDA’s Enforcement Report published it on Jul 4, 2018.
- FDA terminated it on Mar 8, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Inc., of Sylmar, CA.
- 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 331,357 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.