Medline ReNewal Reprocessed Livewire Catheters Recall: Bacterial Endotoxin Risk
Medline recalls specific reprocessed Livewire catheters due to potential bacterial endotoxin levels. Affected units include model numbers 401582R, 401904R, 401905R, 401933R, and 401991R with certain lot numbers. Contact Medline for details.
Lower-risk recall
Devices may have higher than expected amounts of bacterial endotoxin.
Contact the company
What happened, in plain English
Medline is recalling reprocessed Livewire Steerable Electrophysiology Catheters that may contain higher-than-expected bacterial endotoxin levels. This could pose a risk of infection or other complications during medical procedures. Affected units have specific model numbers and lot numbers listed in the recall notice. Read more at govinfonow.com/recall/52956-medline-renewal-reprocessed-livewire-catheters-recall-bacterial-endotoxin-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52956-medline-renewal-reprocessed-livewire-catheters-recall-bacterial-endotoxin-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1460-2025
Cite this page
“Medline ReNewal Reprocessed Livewire Catheters Recall: Bacterial Endotoxin Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52956-medline-renewal-reprocessed-livewire-catheters-recall-bacterial-endotoxin-risk. Based on FDA recall #Z-1460-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1460-2025%22&limit=1).
Why it’s dangerous
Bacterial endotoxins are components of bacteria that can cause infections when introduced into the body. In medical procedures, these endotoxins could lead to infections or adverse reactions if the catheters are not properly sterilized.
Who’s affected
Healthcare professionals using these catheters for electrophysiology procedures are most at risk. Patients receiving these catheters during medical treatments may be affected if the device is used without proper sterilization.
How to tell if you have this one
Check for model numbers 401582R, 401904R, 401905R, 401933R, or 401991R with lot numbers EP240528 or EP240805. The catheters were sold with specific UDI-DI numbers listed in the recall notice.
- Brand
Medline- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number and lot number on the catheter packaging to confirm if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
FDA distribution: “US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Illinois, Iowa, Kansas, Oregon, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1460-2025 (February 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1460-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.