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Reprocessed Livewire Steerable Diagnostic Electrophysiology… recallZ-1321-2026 · Medline Industries, LP · initiated Dec 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1321-2026
Status
Open, Classified
Initiated by the company
Dec 22, 2025
Posted by the FDA
Feb 6, 2026
Recalling firm
Medline Industries, LP
Quantity
41
Product code
NLH
FDA submissions
K221067
Distribution
Distribution US nationwide.

Product description

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;

Code information (models, lots, serial numbers)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

26 devices cleared under K221067 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98277).

Sources and updates

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