Jadak Barcode Scanner
Medical device recall Z-0814-2016. Published in FDA’s Enforcement Report on Feb 24, 2016.
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 Feb 24, 2016. 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
- 9,345 units 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?
Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.
9,345 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
14488129 14488133 14488134 14463683 14463684 14463687 14463688 14463689 14463690 14463691 14463692 14463693 14463694 14463695 14463696 14463697 14463698 14463700 14463701 14463702 14463703 14463704 14463707 14463708 14463709 14463710…
Every code shown here, 1,998 characters
14488129 14488133 14488134 14463683 14463684 14463687 14463688 14463689 14463690 14463691 14463692 14463693 14463694 14463695 14463696 14463697 14463698 14463700 14463701 14463702 14463703 14463704 14463707 14463708 14463709 14463710 14463711 14463712 14463713 14463714 14463715 14463716 14463717 14467646 14467647 14513579 13941887 13941888 13941889 13941890 13941891 13941892 13941893 13941894 13941895 13941896 13941897 13941898 13941899 13943819 13943820 13972753 14474968 14510555 14510556 14510165 14510164 14510494 14510495 14510557 14510559 14510561 14510563 14510564 14510565 14510569 14510570 14510571 14510572 14454894 14477691 14477692 14477693 14477694 14477695 14477696 14477697 14477698 14477699 14477700 14477701 14477702 14477703 14477704 14477705 14495537 14387081 14387087 14387088 14387089 14387090 14387091 14387093 14387094 14387095 14387098 14387099 14387100 14387101 14387102 14387103 14387104 14387105 14387106 14387107 14405257 14405258 13966765 13966766 13966767 13966768 13966769 13966770 13966771 13966772 13966773 13966774 14398441 14398442 14398443 14398446 14398447 14398448 14398449 14398450 14398451 14398453 14398455 14398456 14398457 14398458 14398460 14398461 14398462 14398463 14398465 14398466 14398467 14398468 14469978 14475143 14440312 14440314 14440315 14440317 14232880 14232881 14232884 14232890 14232892 14250969 14043833 14043835 14043837 14043839 14463731 14463732 14463734 14463735 14463736 14398404 14423374 14423375 14423376 14423377 14423379 14423380 14423381 14423382 14423383 14423384 14423385 14423386 14423388 14423389 14423390 14423391 14423392 14423393 14423394 14423395 14423396 14423397 14423400 14423401 14423402 14423403 14423404 14232847 14232850 14232856 14232858 14232861 14232862 14232864 14232865 14232866 14232867 14232869 14232870 14232871 14232873 14232874 14232916 14248133 14248134 14248135 14248136 14248137 14248138 14248139 14248140 14248141 14248142 14248143 14248144 14248145 14248146 14248147 14390571 14390573 14390574…
FDA’s list runs to 86,211 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.
Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.
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.
The words say it went outside the United States too.
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 Jan 15, 2016.
- FDA classified it on Feb 16, 2016.
- FDA’s Enforcement Report published it on Feb 24, 2016.
- FDA terminated it on May 8, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, 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 86,211 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.