FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
- Recall number
- Z-1460-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
- Status
- Open, Classified
- Initiated
- 2025-02-06
- Posted
- 2025-03-26
- Terminated
- not on file
- Reason
- Devices may have higher than expected amounts of bacterial endotoxin.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 74 units
- Distribution
- US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K221067"]
- PMA numbers
- not on file
- Product code
- NLH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28