CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Front/Back Apron with Stretch Velcro Closure recalled
Burlington Medical is recalling Front/Back Apron with Stretch Velcro Closure, Product Number Euro, Part Numbers Ecseeuroa, 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-2125-2019
- 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
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*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.
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: 381839 382008 381834 423928 423922 423917 423919 423921 423916 387073 423925 387072 423918 419789 387168 423923 423926 423924 387116 391152 381819 381824 391111 391093 387078 381786 382901 419907 419906 403296 382883 387075 391159 382894 391166 418938 387975 418911 382881 403349 405569 443366 377104 423704 403406 419550 419902 419903
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 |