Burlington Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
37
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1756-2026Class IIBurlington Medical, Frontal ApronsFebruary 11, 2026
Z-1753-2026Class IIBurlington Medical, Thyroid Shield.February 11, 2026
Z-1763-2026Class IIBurlington Medical, Demi Half Aprons.February 11, 2026
Z-1765-2026Class IIBurlington Medical, Kilt Blockers.February 11, 2026
Z-1754-2026Class IIBurlington Medical, VestFebruary 11, 2026
Z-1759-2026Class IIBurlington Medical, Protective Sleeves.February 11, 2026
Z-1762-2026Class IIBurlington Medical, Half Aprons.February 11, 2026
Z-1764-2026Class IIBurlington Medical, Blockers.February 11, 2026
Z-1755-2026Class IIBurlington Medical, KiltFebruary 11, 2026
Z-1757-2026Class IIBurlington Medical, Wrap Aprons.February 11, 2026
Z-1758-2026Class IIBurlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.February 11, 2026
Z-1761-2026Class IIBurlington Medical, Leg Wraps.February 11, 2026
Z-1760-2026Class IIBurlington Medical, Caps.February 11, 2026
Z-2112-2019Class II2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECJune 7, 2019
Z-2129-2019Class IIPorta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: ProductsJune 7, 2019
Z-2117-2019Class IIPeak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F ProductJune 7, 2019
Z-2111-2019Class II1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111June 7, 2019
Z-2125-2019Class IIFront/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROBJune 7, 2019
Z-2109-2019Class IIFrontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM June 7, 2019
Z-2122-2019Class IIThyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-June 7, 2019