Unify Quadra, Sterile EO
Medical device recall Z-2328-2018. 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
- 22132 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 Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
22132, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 833542 828254 839337 827033 830536 830473 828959 830498 827015 1018188 833598 833523 827104 840503 833586 1049882 833556 839049 833566 839074 827025 839035 839036 839029 830549 833812 833565 839018 833597 833626 839305 833511…
Every code shown here, 2,000 characters
Serial #: 833542 828254 839337 827033 830536 830473 828959 830498 827015 1018188 833598 833523 827104 840503 833586 1049882 833556 839049 833566 839074 827025 839035 839036 839029 830549 833812 833565 839018 833597 833626 839305 833511 830503 822331 833536 1018242 822358 1018196 1049628 1018227 833898 839030 1018251 828334 827066 822343 822323 791985 792101 822370 822355 822345 822341 822322 792090 822356 822361 792111 791982 791992 822328 792106 822362 792114 792113 822363 822346 827040 822326 792097 822329 792095 792112 791998 822335 822317 791977 827070 822338 792092 822347 792002 827097 822321 792087 791994 827109 827012 822354 792099 827088 791993 822334 1049636 827037 822332 1065676 833576 833823 833539 833862 833833 833561 831076 830523 833507 833568 833622 833880 833580 833789 833854 833569 833602 833824 833827 833629 833885 833630 833897 833856 833573 833601 833828 833788 833587 833845 833886 833570 833583 833815 833871 833554 833825 833798 833884 833779 833533 833843 833777 833872 833575 833519 833851 833848 833894 833806 833819 833521 833883 833535 833589 833850 833817 833841 833555 833858 833834 833579 833847 833518 833528 833529 833616 833590 833895 833596 839086 833600 833795 833786 833892 833784 833873 833524 833818 833614 833606 833623 833860 833794 833564 1065683 1049634 1050071 1050077 828253 833775 1065679 837803 822330 1018184 839015 831064 840443 828312 840570 833774 833558 839048 833830 840515 833852 828984 833831 833855 840447 840504 837811 1018248 831084 1018253 1049646 1065673 840483 1018217 831050 827102 827108 840499 839014 827024 1018249 1018268 828267 829015 828336 1050073 837818 828946 840566 1018231 840527 1166559 791991 1018193 792104 839302 822352 833517 822366 833610 827076 830495 833802 840453 1018215 828311 833838 840540 833599 833809 830521 839294 791987 837791 830505 1049883 839079 837771 827086 828986 828952 828998 829010 833853 1018257 828939 833591 839338 1018269 833804 827006 827019 828305 827046 827059 827048 840457 827010…
FDA’s list runs to 184,832 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 184,832 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.