Burlington Medical LLC
Newport News, VA, US
BURLINGTON MEDICAL, LLC appears in FDA device records in Newport News, VA. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 37 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1222742 | 1000120804 | BURLINGTON MEDICAL, LLC | 3 ELMHURST ST., Newport News, VA 23603 US | 2026 | |
| 3032848578 | 3032848578 | Burlington Medical LLC | 700 Thimble Shoals Blvd., Newport News, VA 23606 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 37| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1765-2026 | Burlington Medical, Kilt Blockers. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1764-2026 | Burlington Medical, Blockers. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1763-2026 | Burlington Medical, Demi Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1762-2026 | Burlington Medical, Half Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1761-2026 | Burlington Medical, Leg Wraps. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1760-2026 | Burlington Medical, Caps. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1759-2026 | Burlington Medical, Protective Sleeves. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1758-2026 | Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1757-2026 | Burlington Medical, Wrap Aprons. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1756-2026 | Burlington Medical, Frontal Aprons | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1755-2026 | Burlington Medical, Kilt | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1754-2026 | Burlington Medical, Vest | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-1753-2026 | Burlington Medical, Thyroid Shield. | Potential for attenuation degradation over time, decreasing the lifespan. | Class II | Open, Classified | |
| Z-2130-2019 | Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T 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. | 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. | Class II | Terminated | |
| Z-2129-2019 | Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 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. | 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. | Class II | Terminated | |
| Z-2128-2019 | Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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. | 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. | Class II | Terminated | |
| Z-2127-2019 | Cap, Product Number Cap, Part Numbers CAP1, CAP2 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. | 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. | Class II | Terminated | |
| Z-2126-2019 | Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 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. | 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. | Class II | Terminated | |
| Z-2125-2019 | 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. | 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. | Class II | Terminated | |
| Z-2124-2019 | Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M 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. | 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. | Class II | Terminated | |
| Z-2123-2019 | Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL 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. | 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. | Class II | Terminated | |
| Z-2122-2019 | Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R 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. | 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. | Class II | Terminated | |
| Z-2121-2019 | Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP 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. | 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. | Class II | Terminated | |
| Z-2120-2019 | 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M 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. | 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. | Class II | Terminated | |
| Z-2119-2019 | Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R 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. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain