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Reprocessed Electrophysiology Catheters and Ultrasound… recallZ-2615-2026 · Medline Industries, LP · initiated May 15, 2026

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

Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

FDA root cause category: Under Investigation by firm

What the company is doing

This is an expansion of recall RES 98277. On May 15, 2026, firm notified affected consignee via letter titled "URGENT MEDICAL DEVICE RECALL". All affected product has expired. The consignee was instructed to quarantine all affected product and destroy it.

Recall details

Recall number
Z-2615-2026
Status
Open, Classified
Initiated by the company
May 15, 2026
Posted by the FDA
Jul 2, 2026
Recalling firm
Medline Industries, LP
Quantity
3
Product code
NLH
FDA submissions
K241156
Distribution
US Nationwide distribution in the state of TX.

Product description

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.

Code information (models, lots, serial numbers)

Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.

Devices named in this recall

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

Other devices under the same FDA submission

24 devices cleared under K241156 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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