Z-1460-2025Class II

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R...

Name: Z-1460-2025 Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-06
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-06 / Open, Classified / root cause: sterility

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R on 2025-02-06. FDA classified it as Class II and gives the reason as "Devices may have higher than expected amounts of bacterial endotoxin". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1460-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-06
Posted: 2025-03-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: Devices may have higher than expected amounts of bacterial endotoxin.
Root cause tag: sterility
FDA 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 in commerce: 74 units
Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1460-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26

Product code NLH

K221067Class IIMedline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service and Savings, Inc. / cleared 2023-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)