CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report

2 pc Full Wrap Vest & Kilt, Product Number VK recalled

Burlington Medical is recalling 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers Ecrevka, Ecrevkb, Ecrevkc, distributed nationwide in the US. The recall was initiated on 7 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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 381906 381908 391122 387793 381907 391085 385629 385742 387992 391126 382927 382934 385609 387811 382904 385593 419797 423948 414766 418983 387976 419889 391137 387979 381814 385729 419786 419785

Quantity recalled310

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2112-2019
FDA event ID: 83144
Recalling firm: Burlington Medical, Newport News, VA
Classification: Class II
Status: Terminated
Recall initiated: 7 Jun 2019
FDA classified: 30 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

7 Jun 2019	Recall initiated by company
30 Jul 2019	Classified by FDA	+53 days
7 Aug 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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 381906 381908 391122 387793 381907 391085 385629 385742 387992 391126 382927 382934 385609 387811 382904 385593 419797 423948 414766 418983 387976 419889 391137 387979 381814 385729 419786 419785

Where was it sold?

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

23 other products · FDA event 83144

This product is part of a recall event; the main page for the event is Frontal Apron with Quick Drop Velcro Closure (no elastic) recalled.

Reported	Class	Recall	Company	Reason	Where
7 Aug 2019	CLASS II	Frontal Apron with Quick Drop Velcro Closure (no elastic) recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Apron Velcro Closure, Product Number F recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Support Belt Apron, Product Number F recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Overlap Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	2 pc Full Overlap Vest & Kilt, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Front/Back Apron with Stretch Velcro Closure recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Kilt, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Sleeve, Product Number Sleeve, Part Numbers Resl, SL recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar, Buckle Closure, Product Number TS4 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar Oversize, Product Number TS3 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar, Magnetic Closure, Product Number TS5 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	2 pc Full Wrap Vest & Kilt Back-Saver , Product Number Pvk recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Porta Shield, Product Number Porta Shield recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Quick Drop OR Apron, Product Number recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Half Apron, Product Number Half Apron, Part Numbers Rehalf*, REHALF3 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Cap, Product Number Cap, Part Numbers CAP1, CAP2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Peak Vest, Single recalled by Burlington Medical	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	1 pc Full Wrap Support Belt Apron, Product Number F111 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Thyroid Collar, Velcro Closure, Product Number TS2 recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	Frontal Stretch Buckle Closure Apron, Product Number recalled	Burlington Medical	Other	Nationwide
7 Aug 2019	CLASS II	1 pc Full Wrap Back Relief Apron recalled by Burlington Medical	Burlington Medical	Other	Nationwide

More recalls from Burlington Medical

All 37

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	BAT (Breast, Axilla and Thyroid) Coverage recalled by Burlington Medical	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Kilt recalled	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Caps recalled	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Thyroid Shield recalled by Burlington Medical	Burlington Medical	Potency & Assay	Nationwide
8 Apr 2026Device	CLASS II	Burlington Medical, Blockers recalled	Burlington Medical	Potency & Assay	Nationwide

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled	Canon Medical System USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederl	Potency & Assay