Drug recall
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models…
FDA recall event 97357 · Class I · MEDLINE INDUSTRIES, LP - Northfield
Key facts
| Event ID | 97357 |
|---|---|
| Recall numbers | Z-2460-2025 |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Product type | Devices |
| Products | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. |
| Initiation date | Jul 14, 2025 |
| Report date | Sep 3, 2025 |
| City | Northfield |
| State | IL |
| Country | United States |
| FEI number | 1417592 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: