ReNewal Livewire Catheter (Medline) – endotoxin levels (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528, 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528, 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805, 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528, 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528, 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528
Products Sold
401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528;
MEDLINE INDUSTRIES, LP Northfield is recalling Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 40 due to Devices may have higher than expected amounts of bacterial endotoxin.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices may have higher than expected amounts of bacterial endotoxin.
Recommended Action
Per FDA guidance
An IMMEDIATE ACTION REQUIRED notification letter dated 2/6/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent FedEx return labels to return the product back to Medline ReNewal (if applicable). Your account will receive credit or replacement when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. If you have any questions, please contact 866-359-1704.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026