Burlington Medical, LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1757-2026Class IIBurlington Medical, Wrap Aprons.February 11, 2026
Z-1761-2026Class IIBurlington Medical, Leg Wraps.February 11, 2026
Z-1763-2026Class IIBurlington Medical, Demi Half Aprons.February 11, 2026
Z-1762-2026Class IIBurlington Medical, Half Aprons.February 11, 2026
Z-1765-2026Class IIBurlington Medical, Kilt Blockers.February 11, 2026
Z-1756-2026Class IIBurlington Medical, Frontal ApronsFebruary 11, 2026
Z-1759-2026Class IIBurlington Medical, Protective Sleeves.February 11, 2026
Z-1753-2026Class IIBurlington Medical, Thyroid Shield.February 11, 2026
Z-1755-2026Class IIBurlington Medical, KiltFebruary 11, 2026
Z-1758-2026Class IIBurlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.February 11, 2026
Z-1754-2026Class IIBurlington Medical, VestFebruary 11, 2026
Z-1764-2026Class IIBurlington Medical, Blockers.February 11, 2026
Z-1760-2026Class IIBurlington Medical, Caps.February 11, 2026
Z-2115-2019Class IIOverlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESJune 7, 2019
Z-2121-2019Class IIThyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-RJune 7, 2019
Z-2107-2019Class IIFrontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA1June 7, 2019
Z-2113-2019Class IIVest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REJune 7, 2019
Z-2130-2019Class IIThyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTSJune 7, 2019
Z-2128-2019Class IIHood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to proJune 7, 2019
Z-2110-2019Class IIFrontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XJune 7, 2019