2 pc Full Wrap Vest & Kilt, Product Number VK
Medical device recall Z-2112-2019. Published in FDA’s Enforcement Report on Aug 7, 2019.
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 Aug 7, 2019. 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
- 310 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 protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
310, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 442293 443188 385619 387938 385611 385530 381778 387881 381782 387884 381781 387890 381843 387940 391124 387889 381780 387880 419929 418856 385607 387808 382887 391161 382951 381851 382896 385579 385748 381856 381857 381946…
Every code shown here, 1,994 characters
Serial Numbers: 442293 443188 385619 387938 385611 385530 381778 387881 381782 387884 381781 387890 381843 387940 391124 387889 381780 387880 419929 418856 385607 387808 382887 391161 382951 381851 382896 385579 385748 381856 381857 381946 387866 423956 387877 423947 387872 423942 387871 423987 387863 423960 387869 424000 423961 387873 387864 419806 387870 419807 419776 423855 387874 423998 419774 419808 419770 419795 419775 419803 418868 419800 387867 419804 382803 391117 382956 382870 382941 382869 419942 419870 419943 418846 381831 385673 1111384500 382794 419934 418859 385610 385535 385735 385620 385740 385616 385533 385624 418779 387968 418789 418752 384333 382911 382878 382945 382856 382926 381903 381913 381864 391068 414763 418992 382959 382797 387924 418985 414044 423560 414346 414117 417567 419809 442291 443283 387865 418956 423601 384488 385626 385529 385724 387956 382962 379689 419937 418881 385697 418946 423979 391149 385634 381797 385636 387991 387987 387901 381794 387995 387957 418809 387960 418817 387898 418776 387977 418777 381804 418795 391156 418770 391151 418771 385637 387999 381904 385525 419847 387962 418895 387923 382985 382928 381850 381806 381830 381852 381872 391078 385633 385662 385622 385716 385627 385677 419944 419778 384477 384489 419913 423860 419945 419855 391125 381848 444520 443809 444290 443820 443801 443811 443344 426767 419938 423973 419940 418984 381846 387854 391131 385722 391157 382884 387970 388000 391106 385578 382892 385592 387142 387132 384496 387147 384475 384379 384381 384498 382942 384401 391127 385728 391105 382907 382979 382855 443307 443372 382987 384416 382836 382804 382965 391062 391120 382929 443402 443268 443220 443401 443817 443819 443315 442292 442290 443308 444717 444736 443346 427182 382970 387184 382977 382800 382910 382774 391065 382790 382795 382776 382939 382806 391058 382779 387950 419874 385621 385713 387868 418860 382971 384390 385730 391119 442294 443301 443302 442295 443371 443305 444718 443304…
FDA’s list runs to 2,189 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.
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
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 Jun 7, 2019.
- FDA classified it on Jul 30, 2019.
- FDA’s Enforcement Report published it on Aug 7, 2019.
- FDA terminated it on Apr 28, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Burlington Medical, LLC, of Newport News, VA.
- 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 2,189 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.