Unify Assura, Sterile EO
Medical device recall Z-2327-2018. 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
- 65048 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 Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
65048, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1037182 1005203 1042043 1035639 1043218 1038138 1057760 1043082 1042007 1038370 1043174 1035637 1004332 1043052 1043193 1013295 1006465 1037200 1004314 1005220 1006461 1006445 1004293 1006495 1005191 1005222 1004302 1004329…
Every code shown here, 1,994 characters
Serial #: 1037182 1005203 1042043 1035639 1043218 1038138 1057760 1043082 1042007 1038370 1043174 1035637 1004332 1043052 1043193 1013295 1006465 1037200 1004314 1005220 1006461 1006445 1004293 1006495 1005191 1005222 1004302 1004329 1059129 1005200 1006447 1005214 1005195 1006472 1006452 1004307 1005228 1006507 1040448 1042005 1006480 1004324 1005219 1004310 1005206 1041981 1013287 1006485 1006456 1004309 1040418 1040482 1037151 1043051 1040431 1040424 1038164 1038165 1004308 1013319 1041966 1043214 1043050 1035638 1059136 1040472 1043206 1059150 1035648 1059146 1058494 1058489 1038173 1038192 1038176 1037183 1037144 1041952 1042035 1043046 1040439 1006500 1041945 1035672 1043038 1004322 1005223 1013324 1006491 1037209 1005216 1013300 1038145 1038377 1006475 1038183 1041949 1038372 1042021 1038185 1006443 1043065 1038166 1043201 1038171 1043057 1040489 1043060 1037171 1057759 1038151 1059133 1041970 1042028 1043040 1040437 1040441 1004304 1038197 1040409 1041944 1043176 1004301 1006504 1040481 1040423 1005225 1059130 1042046 1038201 1042047 1042041 1013317 1037181 1059131 1059142 1043183 1006510 1042052 1038175 1058491 1077954 1077980 1077983 1077957 1077955 1077978 1035654 1005230 1058502 1043198 1035670 1041993 1038191 1043074 1042015 1043191 1035675 1006462 1038168 1006484 1041996 1035649 1042013 1006468 1013325 1013313 1057775 1041969 1043200 1043091 1040454 1043070 1043042 1013345 1043089 1038140 1013312 1043222 1006482 1038179 1038146 1037173 1059141 1037157 1059127 1037198 1042050 1013314 1037206 1077966 1037189 1037187 1040410 1038150 1006481 1037164 1043187 1037154 1013330 1038162 1043044 1041961 1038189 1038156 1040412 1058501 1038143 1006446 1004319 1038366 1004295 1037145 1035669 1038381 1040453 1040474 1005238 1041986 1059126 1042024 1059125 1038128 1043048 1035640 1059122 1040434 1038132 1043195 1042034 1038169 1043199 1038135 1058490 1038198 1058493 1038167 1038384 1042017 1038383 1058492 1043056 1037160 1077977 1043205 1059132 1035658 1040411…
FDA’s list runs to 581,706 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 581,706 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.