Kaneka LIPOSORBER LA-15 System Recall: Risk of Severe Anaphylactoid Reactions
Kaneka recalls LIPOSORBER LA-15 LDL Adsorption Columns for patients on ACE inhibitors due to risk of severe anaphylactoid reactions including shock.
Use caution until it’s fixed
Labeling change to due to the risk of severe anaphylactoid reactions including shock in patients treated with the Liposorber LA-15 LDL Adsorption Column under concomitant ACE inhibitor medication treatment.
Contact the company
What happened, in plain English
Kaneka is recalling its LIPOSORBER LA-15 system because it can cause severe allergic reactions in patients taking ACE inhibitor medications. This risk requires immediate attention to prevent life-threatening reactions. Read more at govinfonow.com/recall/61137-kaneka-liposorber-la-15-system-recall-risk-of-severe-anaphylactoid.
Source Summary by GovInfoNow · govinfonow.com/recall/61137-kaneka-liposorber-la-15-system-recall-risk-of-severe-anaphylactoid · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0900-2022
Cite this page
“Kaneka LIPOSORBER LA-15 System Recall: Risk of Severe Anaphylactoid Reactions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61137-kaneka-liposorber-la-15-system-recall-risk-of-severe-anaphylactoid. Based on FDA recall #Z-0900-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2022%22&limit=1).
Why it’s dangerous
The LIPOSORBER LA-15 LDL Adsorption Column can cause severe anaphylactoid reactions, including shock, when used with ACE inhibitor medications. This reaction can be life-threatening and requires immediate medical attention.
Who’s affected
Patients using the LIPOSORBER LA-15 system with ACE inhibitor medications are at risk. Those with a history of severe allergic reactions may also be affected.
How to tell if you have this one
Check for the LIPOSORBER LA-15 system with product numbers 101445 (MA-03) and disposables like #101447, #101473, #101785, #101786, #101788, or #101789. All product lot and UDI numbers are affected.
- Brand
Kaneka- Category
Medical device
What to do — step by step
Check for Allergic Reactions
If you experience symptoms like swelling, difficulty breathing, or shock after using the LIPOSORBER LA-15 system with ACE inhibitors, seek immediate medical help.
Contact Kaneka
Reach out to Kaneka America Corp for guidance on the recall and potential remedies.
Where it went and when
Where it was distributed
Distributed in 34 states.
FDA distribution: “US only: CA, NH, CT, MA, FL, DE, NY, NJ, PA, OH, MD, VA, NC, SC, GA, MS, TN, TX, IN, AZ, MI, WI, MN, IL, MO, NE, CO, WA, OR, UT, KS, OK, AL, ME” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0900-2022 (February 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0900-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.