FDAMarch 5, 2015device
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
What to do
FDA enforcement status: Terminated
Brands named
maquet cardiovascular us salesmaquetmaquet cardiovascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCJC Sales Recalls Lil' Buddies Pet Laser Toys Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; Violates Mandatory Standard for Consumer Products with Button Cell Batteries2026-04-16
- FDABubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;2026-01-09
- FDAThe product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.2025-08-29
- FDAHeartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
- FDAHeartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.2025-08-15
- FDAVasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting T...2025-08-06
- FDACorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.2025-07-14
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →