Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

• • Ongoing Z-2615-2026 FDA Class I ·initiated 15 May 2026

  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.

• • Ongoing Z-1322-2026 FDA Class I ·initiated 22 Dec 2025

  These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

• • Ongoing Z-2460-2025 FDA Class I ·initiated 14 Jul 2025

  Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.

510(k) Number

K241156 ↗

FDA Product Code

NLH

Device Class

Class II

Regulation

21 CFR Part 870.1220

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) Open recall

  Class II

  FDA 510(k) K250545 Active Cleared 5 Jun 2025

• Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

  Unclassified

  FDA 510(k) K173627 Active Cleared 12 Jul 2018

• Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

  Class II

  FDA 510(k) K171324 Active Cleared 23 Jun 2017

• ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Open recall

  Class II

  FDA 510(k) K232511 Active Cleared 29 Apr 2024

• Medisiss Reprocessed Ultrasonic Instruments

  Unclassified

  FDA 510(k) K124033 Active Cleared 7 Jan 2014

• Reprocessed Arthroscopic Shapers

  Class II

  FDA 510(k) K012667 Active Cleared 3 Jun 2002

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