Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-2611-2025)

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 Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH

Product Classification:

Class I

Date Initiated: July 31, 2025

Date Posted: October 8, 2025

Recall Number: Z-2611-2025

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 BD710DF282CRH 10197344044023; BD710DF282RRH 10197344044030; BD710FJ282CRH 10197344044047; BD710FJ282RRH 10197344044054; LOTS EP241216 EP241218 EP241226 EP241231 EP250110 EP250121 EP250210

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated