FDA Updates Labeling for LIPOSORBER LDL Adsorption Column Due to Anaphylactoid Shock Risk
LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a serious documented risk of anaphylactoid reactions and shock in patients on ACE inhibitors. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product without reported injury receives a High (3) severity score.
Plain-English summary
The FDA has issued a labeling update for the LIPOSORBER System Model LA-15, an LDL Adsorption Column manufactured by Kaneka America Corp. The device is used for plasma treatment to reduce high cholesterol. The updated labeling reflects a documented risk of severe anaphylactoid reactions, including shock, in patients who are taking ACE inhibitor medications while undergoing treatment with this device.
Kaneka America Corp distributed 138 LIPOSORBER systems and 54,703 associated disposables across 34 U.S. states. All product lots and UDI numbers are subject to this labeling change.
The recalled product
- Product
- LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (L
- Manufacturer
- Kaneka America Corp
- Hazard
- anaphylactoid-reaction
- shock
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All product lot and UDI numbers are affected.
Distribution
Distributed in 34 states:
- AL
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IL
- IN
- KS
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- NC
- NE
- NH
- NJ
- NY
- OH
- OK
- OR
- PA
- SC
- TN
- TX
- UT
- VA
- WA
- WI
Related recalls
Same category
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighGE Healthcare AW Server Radiological Image Processing System Software Defect
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateThuvera Laser Console Software Version 2.2 Recall Notice
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01