2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK
Medical device recall Z-2116-2019. 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
- 332 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 Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F 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.
332, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 381795 385536 443407 444693 387809 385555 419989 419866 391144 385552 414184 419956 385597 381894 419988 419822 419992 419961 419912 423985 443459 444691 443411 443313 382943 384393 391038 379532 418751 385727 383000 382932…
Every code shown here, 1,997 characters
Serial Numbers: 381795 385536 443407 444693 387809 385555 419989 419866 391144 385552 414184 419956 385597 381894 419988 419822 419992 419961 419912 423985 443459 444691 443411 443313 382943 384393 391038 379532 418751 385727 383000 382932 382986 382784 381893 385750 387236 382780 378516 381829 382875 391237 443398 443446 443476 444608 443410 443155 387927 385678 382812 382767 387915 418780 419828 419885 419869 423977 381901 385737 385550 385746 381891 385736 385547 387878 442492 443447 387934 387816 387973 387893 384413 391036 391101 382773 419990 418828 443471 444662 382957 384404 391087 385558 385562 385542 385512 385526 414081 414065 391224 382968 382763 382935 391228 382919 391227 382936 379707 377610 420000 419878 419994 419968 423553 419875 391229 381823 426470 443420 391044 382830 418914 418991 443312 443413 385741 381889 419927 387852 381883 381944 385596 381882 381900 385546 419962 423625 418898 418845 419987 423986 419991 419973 384415 382799 382832 382778 419983 423931 419964 387859 418773 418888 443425 444663 387933 387936 382913 382777 382845 382937 381888 385577 385523 385599 418949 419845 423965 418896 391225 387244 418871 423930 387810 385513 419976 423967 418876 418821 419864 423541 381890 385743 419824 418891 381895 382916 423903 419980 391049 384400 423515 419578 426456 429676 385511 391083 382752 382802 443799 443113 444538 443347 385549 385717 387858 387886 382994 382842 387930 418819 419856 418850 423631 414773 391063 391056 387882 418839 418890 379579 443181 443409 391039 384367 444724 443417 385733 381892 385559 385527 382975 382796 385563 385534 385952 384468 418783 418907 418912 418910 418837 418906 418913 418877 384455 382967 385594 391235 443470 444627 391053 382854 387853 418899 382980 382771 418884 423983 418852 419827 414324 414075 385598 382961 419999 418879 414062 414278 418887 387989 391050 382808 382825 382997 391055 382999 384396 391051 385551 418834 382791 384417 381896 381822 444544 426347 418902 418889 387928 387857 418987…
FDA’s list runs to 2,339 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 2,339 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.