Promote, Sterile EO
Medical device recall Z-2322-2018. 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
- 37485 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?
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
37485, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 709757 709778 706480 706481 711414 688003 685487 709738 683775 711424 713640 691372 686757 686823 691331 685597 681345 691377 685532 687976 687986 691387 685495 711497 686842 691364 691327 686773 685441 691399 691375 686795…
Every code shown here, 1,998 characters
Serial #: 709757 709778 706480 706481 711414 688003 685487 709738 683775 711424 713640 691372 686757 686823 691331 685597 681345 691377 685532 687976 687986 691387 685495 711497 686842 691364 691327 686773 685441 691399 691375 686795 691311 686796 685451 691404 691303 685433 705343 691395 705293 705282 685591 706504 686768 691393 705366 691351 711499 713626 819121 711452 829224 713644 809004 808988 711481 711404 711475 711496 713600 713631 713621 713645 713606 791104 711439 713603 711456 711491 713609 808993 761908 713614 711478 786501 791113 711420 713613 713618 711405 761899 763493 763501 763500 791095 791103 786454 796199 796214 796197 796198 796202 791111 761981 761969 761973 832166 832164 832168 791128 791123 791125 791091 791124 791093 791153 791139 791158 791127 791145 786495 791097 791152 791132 791144 786473 791122 786475 791135 791086 832189 796201 796207 791080 796206 791157 791131 791147 791151 791146 796194 796213 832171 832193 796200 832191 832188 827770 791126 776342 780319 786494 786472 791105 829221 827777 827775 796216 827776 827778 776338 780327 796217 786459 786499 786457 796218 786448 786483 780326 791148 776339 827774 832181 832185 832190 786488 796208 796196 796210 827773 796209 796215 796195 796205 796211 796204 832165 780331 780328 791143 786482 786444 791140 791090 791084 791089 791115 791094 786497 791107 791114 786500 791116 791136 791100 791083 791120 786503 786504 791130 791099 786461 791081 791150 786468 786486 791110 791112 791134 791087 791118 786507 786469 791102 786477 786479 791108 786481 786492 827772 786508 786491 832184 829227 832176 786485 791082 786463 832187 786478 780320 776361 786498 780323 776367 776366 780333 776362 786456 780332 776341 776323 776350 776332 786451 786453 786490 786455 786445 776336 786506 786471 786467 786460 786464 786496 786502 776343 776345 780330 776347 780322 776328 776321 776326 786447 773952 786450 776354 786505 786493 776364 776322 786466 780324 776319 776330 786449 776325 776363 776360 776320…
FDA’s list runs to 310,179 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 310,179 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.