Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-2612-2025)

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 Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH

Product Classification:

Class I

Date Initiated: July 31, 2025

Date Posted: October 8, 2025

Recall Number: Z-2612-2025

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 81102RH 10197344133239; 81104RH 10197344133246; 81107RH 10197344133260; 81174RH 10197344133291; 81402RH 10197344133352; 81404RH 10197344133376; 81405RH 10197344133383; 81472RH 10197344133413; 81473RH 10197344133420; 81474RH 10197344133437; 81531RH 10197344133512; 81532RH 10197344133529; LOTS EP250212 EP250214

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated