SunMed Holdings, LLC

FDA Regulatory Profile

Summary

Total Recalls
18 (6 Class I)
510(k) Clearances
0
Inspections
18
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1116-2026Class IBrand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: December 15, 2025
Z-1117-2026Class IBrand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IDecember 15, 2025
Z-1115-2026Class IBrand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number:December 15, 2025
Z-1114-2026Class IBrand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number:December 15, 2025
Z-1904-2025Class IBroselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, May 15, 2025
Z-1814-2025Class IAdult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen TMay 1, 2025
Z-0363-2024Class IIVentlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configuratioOctober 11, 2023
Z-0367-2024Class IIVentlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurationOctober 11, 2023
Z-0364-2024Class IIVentlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configuratiOctober 11, 2023
Z-0369-2024Class IIMedline manual resuscitators with integrated manometer, multiple accessory configurations to includeOctober 11, 2023
Z-0362-2024Class IIVentlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configuraOctober 11, 2023
Z-0366-2024Class IIVentlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurOctober 11, 2023
Z-0361-2024Class IIVentlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory confiOctober 11, 2023
Z-0365-2024Class IIVentlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configuratiOctober 11, 2023
Z-0368-2024Class IICuraplex manual resuscitators with integrated manometer, multiple accessory configurations to includOctober 11, 2023
Z-1019-2023Class IIAir-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 December 22, 2022
Z-1020-2023Class IIAirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 December 22, 2022
Z-1779-2022Class IIFull Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91September 8, 2022