Medline Industries Recalls Reprocessed Electrophysiology Catheters
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Medline Industries, LP is recalling three units of reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters due to potential residual material contamination.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Medline Industries, LP initiated a voluntary recall of specific reprocessed catheters after an expansion of RES 98277. The devices may contain small particles of residual material on patient-contacting surfaces.
Which Products Are Affected
The recall affects three units distributed nationwide in the state of TX under recall number Z-2615-2026. Affected products include:
- Item no. 401206RH, St. Jude Medical Response Diagnostic Electrophysiology Catheter 4 Elec. 10mm (UDI-DI 10197344043767)
- Item no. 401305RH, St. Jude Medical Response Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm (UDI-DI 10197344043637)
Lot: EP250203
What You Should Do
Consumers should follow guidance from the recalling firm regarding the affected devices.
Why This Matters
Use of devices with residual particulates may lead to inflammatory response, systemic infection, granulomatous reaction, thrombus formation, cerebral or pulmonary embolism, or deep vein thrombosis.
Source
FDA recall Z-2615-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,042 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.