FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass I · Medical device · Recalled July 8, 2026

Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no recall — Medline Industries, LP

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2615-2026
Brand
Medline Industries
Classification
Class I
Units affected
3
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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.

Affected products

Companies & origin

Recalling firm location
Northfield, IL, United States
Firm address
3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots
Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637.
Distribution
US Nationwide distribution in the state of TX.
Firm notified the public via
Letter
FDA event ID
99122
Recall initiated
May 15, 2026
FDA classified
July 2, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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