CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
2 pc Full Overlap Vest & Kilt, Single recalled by Burlington Medical
Burlington Medical is recalling 2 pc Full Overlap Vest & Kilt, Single, 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
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-2114-2019
- 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 Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM 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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 382915 418869 443152 443303 443314 443116 443309 443122 443190 443115 385698 387994 387972 423969 381793 419868 385687 414095 419532 391154 423565 387997 385699 387917 382841 382946 382824 391134 384324 382787 381796 418843 387119 384454 384420 391099 382998 391096 382816 382909 423746 423667 382819 381798 384421 381821 384336 381828 385580 384349 423530 418903 423531 423976 419873 382859 418830 391146 419862 387967 418955 385691 391138 385680 385532 385692 387900 382782 384402 382823 382818 391163 382857 382866 382838 382906 381939 382995 381808 382903 391091 391164 381807 382862 418886 391148 418885 385690 391088 385681 391086 385682 391088 384412 381917 384422 384394 443131 443310 382900 385600 385693 391136 385683 391080 384294 384425 423945 387969 444689 443128 381790 418894 385686 391135 385684 385731 385689 381942 443104 444591 387974 419843 443129 443300 417565 391145 382850 382931
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 83144This product is part of a recall event; the main page for the event is Frontal Apron with Quick Drop Velcro Closure (no elastic) recalled.
More recalls from Burlington Medical
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BAT (Breast, Axilla and Thyroid) Coverage recalled by Burlington Medical | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Kilt recalled | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Caps recalled | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Thyroid Shield recalled by Burlington Medical | Burlington Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Burlington Medical, Blockers recalled | Burlington Medical | Potency & Assay | Nationwide |
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| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |