Recall Z-1322-2026— Medline Industries, LP

Name: FDA recall Z-1322-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-22

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2025-12-22. It names one FDA 510(k) clearance: K241156. Product: Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH. Reason: 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.

Recalling firm: Medline Industries, LP
Classification: Class I
Status: Ongoing
Initiated: 2025-12-22
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K241156 — 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, 401Surgical Instrument Service and Savings, Inc.·cleared 2024-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.