Fortify, Sterile EO
Medical device recall Z-2320-2018. 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
- 81338 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?
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
81338, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1088287 1086945 791534 803774 1088281 1238556 1238547 1205582 1238546 1238550 1238549 1238555 1225890 1241948 1238542 1208712 1238553 1203728 1242808 1241596 1204938 1241585 1241601 1243063 1236460 1224005 1241592 1242398 1242701…
Every code shown here, 1,997 characters
Serial #: 1088287 1086945 791534 803774 1088281 1238556 1238547 1205582 1238546 1238550 1238549 1238555 1225890 1241948 1238542 1208712 1238553 1203728 1242808 1241596 1204938 1241585 1241601 1243063 1236460 1224005 1241592 1242398 1242701 1238608 1236436 1238603 1243251 1238600 1223990 1239853 1189142 1208713 1205609 1238601 1223995 1239852 1239854 1239848 1252018 1252033 1239856 1238548 1238544 1205578 1205607 1238605 1238604 1223980 1197908 1204945 1236435 1164056 1220447 1203416 1205466 1220445 1220458 1203410 1239173 1236889 1080885 1080870 798885 1046083 1080886 1080884 1083520 791593 1033647 791595 791526 837528 821990 1236904 1209764 1232792 1252023 1197906 1197914 1197913 1197910 1199394 1086922 1064897 1064898 1033645 803775 803815 803762 803789 798875 1208046 803796 798928 803806 803760 798909 798913 803794 803803 803807 803802 803808 803813 798935 803793 803763 803819 803781 827428 803765 803782 798854 798861 803784 803776 798866 803780 798851 798948 803779 803823 803783 803786 803792 803810 803761 798893 803820 798988 803777 803791 803799 798837 803787 798855 798929 803764 803795 803822 803768 798959 803797 798905 803785 803821 803814 803790 803804 803788 803818 803778 798870 803817 803816 803801 1046067 803773 1029026 832739 1236891 1061127 1029038 840059 1029037 1062292 1223993 1236442 1249208 1223985 1208044 1223983 1224006 1248872 1233390 1223999 1236426 1205616 823030 823006 823058 823018 823052 823070 823036 823010 823061 823033 822997 823028 823022 823044 823075 823063 823079 822993 823025 823049 823016 821984 821974 823024 822006 826790 823003 826756 826803 826773 823085 826791 823059 826808 826793 826783 822995 823084 826758 823001 822996 826780 823027 822001 826752 822008 826801 826770 826797 826768 826759 822994 823014 822998 823062 823083 823050 823065 823051 823053 823034 823037 823026 823023 823060 821982 823045 823021 823041 822999 823008 826805 823056 823076 823086 821993 823046 823067 823012 822011 823077 823068 823015 823019 822007…
FDA’s list runs to 663,543 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 663,543 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.