CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Frontal Apron Velcro Closure, Product Number F recalled
Burlington Medical is recalling Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, 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-2108-2019
- 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
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM 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: 387753 418758 414016 391249 381983 418764 381922 382933 382905 418853 387833 387759 423728 387770 387822 418760 418772 418762 418763 381759 414197 387955 443477 391067 418826 391060 387776 387777 387821 387758 387780 387769 387754 387824 387825 387826 423927 391167 387790 387182 391129 418883 442325 387838 359614 423723 443487 385516 381988 440775 384395 381987 381989 387227 418861 391057 443280 443272 443297 443298 419544 418943 387980 387823 423993 387818 384356 387174 444307 403409 440808 403707 410471 403144 440783 440810 405598 391103 382954 423708 387768 385674 419916 418941 423715 403737 423733 382889 381921 382984 391061 414010 418858 443292 385515 385522 387167 387239 387982 387752 418833 418958 418807 423861
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 |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |