Medline Industries Recalls Reprocessed St. Jude Diagnostic Electrophysiology Catheters Due to Contamination Risk
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Medline Industries, LP has issued a Class I recall for 48 reprocessed St. Jude diagnostic catheters that may contain residual material, posing risks of infection or embolism.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP has initiated a voluntary Class I recall of specific lots of reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters. The FDA has classified this as a Class I recall, indicating a high risk of serious health consequences. The affected devices may contain small particles of residual material. If used, these contaminated catheters can cause inflammatory responses, systemic infections, granulomatous reactions, or thrombus reactions, which may lead to life-threatening conditions such as cerebral or pulmonary embolism or deep vein thrombosis.
Which Products Are Affected
The recall involves 48 units distributed nationwide across the United States. Affected products include various models of reprocessed St. Jude Medical Supreme Diagnostic Electrophysiology Catheters (4 Elec. and 6 Elec.) with the following model numbers:
- 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
- 4 Elec. 5-5-5mm: 402012RH
- 4 Elec. 5mm: 402004RH
- 6 Elec. 2-5-2mm: 402010RH
- 6 Elec. 5-5-5mm: 402008RH, 402009RH
Affected lot numbers include EP250307 and EP250317. The recall is identified by FDA Recall Number Z-1322-2026.
What You Should Do
Medline Industries began notifying customers via letter on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and not used for patient procedures. For information regarding returns or further instructions, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.
Why This Matters
This recall is significant because the presence of foreign particles in medical devices used in the cardiovascular system can lead to severe, potentially fatal complications, including strokes or blood clots in the lungs.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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