Eight Medical Recirculator 8.0s Disposable Lavage Kit: Aluminum Ion Release Risk
Eight Medical recalls Recirculator 8.0s Disposable Lavage Kits (product code 8100) due to potential aluminum ion release during warming therapy. Affected units include specific lot numbers from 19854184 to 20202106.
Lower-risk recall
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Contact the company
What happened, in plain English
Eight Medical is recalling Recirculator 8.0s Disposable Lavage Kits (product code 8100) because they may release aluminum ions during warming therapy, which could expose patients to a risk. This recall affects specific lot numbers and is part of their Hyperthermic Perfusion System. Read more at govinfonow.com/recall/62388-eight-medical-recirculator-8-0s-disposable-lavage-kit-aluminum-ion.
Source Summary by GovInfoNow · govinfonow.com/recall/62388-eight-medical-recirculator-8-0s-disposable-lavage-kit-aluminum-ion · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2005-2021
Cite this page
“Eight Medical Recirculator 8.0s Disposable Lavage Kit: Aluminum Ion Release Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62388-eight-medical-recirculator-8-0s-disposable-lavage-kit-aluminum-ion. Based on FDA recall #Z-2005-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2005-2021%22&limit=1).
Why it’s dangerous
The device may release aluminum ions during warming therapy under certain conditions, which could expose patients to potential aluminum ion release. This risk is related to the Hyperthermic Perfusion System used to raise body cavity temperatures.
Who’s affected
Patients using the Recirculator 8.0s Disposable Lavage Kit for Hyperthermic Perfusion therapy are most at risk. The recall applies to specific lot numbers produced between 19854184 and 20202106.
How to tell if you have this one
Check the product code number 8100 on the kit. Look for lot numbers listed: 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, 20021361, 20202106, and 18687686.
- Brand
Eight Medical- Product
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for lot numbers on the kit: 19854184, 19854185, 19854186, 20018480, 20019438, 20021361, 20202106, and 18687686.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide, Colombia, and Dubai.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a remedy for this recall?
The recall record states the remedy is null, meaning no specific action is required beyond checking the lot number.
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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-2005-2021 (June 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2005-2021 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.