Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-2613-2025)

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 ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH

Product Classification:

Class I

Date Initiated: July 31, 2025

Date Posted: October 8, 2025

Recall Number: Z-2613-2025

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 D087031RH 10197344019557 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