Z-1321-2026Class I

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology...

Name: Z-1321-2026 Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology...
Creator: Medline Industries, LP
Published: 2025-12-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-12-22 / Open, Classified

FDA source

Medline Industries, LP began a recall of Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH... on 2025-12-22. FDA classified it as Class I and gives the reason as "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1321-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-22
Posted: 2026-02-06
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
Product code: NLH Catheter, Recording, Electrode, Reprocessed
Reason for recall: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
FDA root cause: Under Investigation by firm
Action: On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.
Quantity in commerce: 41
Distribution: Distribution US nationwide.
Product codes and lots: 401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630; 401940RH UDI-DI 10888277407480 Lot EP250618; 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630; 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618; 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630; 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1319-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1320-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1321-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1322-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1323-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1324-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06
Z-1325-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

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)