Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item… — Class I medical device recall Z-2615-2026
Ongoing recall by Medline Industries, LP, reported 2026-07-08, distributed nationwide. Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual materia
| Recall number | Z-2615-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-05-15 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10197344043637, 10197344043767 |
| Lot numbers | EP250203 |
| Model numbers | 401206RH, 401305RH |
Product
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2615-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.