Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-2614-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH

Product Classification:

Class I

Date Initiated: July 31, 2025

Date Posted: October 8, 2025

Recall Number: Z-2614-2025

Event ID: 97496

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7913 eaches

Code Information:

Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500; 10135936RH (For use on Siemens Systems) 10197344026517; LOTS EP241021 EP241114 EP241226 EP250213 LOTS EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219

Distribution Pattern:

Domestic US distribution nationwide. International distribution pending. No international distribution.

Voluntary or Mandated:

Voluntary: Firm initiated