Reprocessed St — Class I medical device recall Z-1322-2026
Ongoing recall by Medline Industries, LP, reported 2026-02-18, distributed nationwide. These lots of reprocessed catheters may contain small particles of residual material. If affected devices are
| Recall number | Z-1322-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-12-22 |
| Classified | 2026-02-06 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 48 |
| UPC / GTIN / UDI-DI | 10197344043439, 10197344043460, 10197344043484, 10197344043491, 10197344043583, 10197344043613, 10197344043620, 10197344043651, 10197344043668, 10197344043682, 10197344043699, 10197344043705, 10197344043712, 10197344043736, 10197344043835, 10197344044245, 10197344044252, 10197344044283, 10197344044290, 10197344044306, 10197344044313, 10197344044351, 10197344044382, 10197344044436, 10197344044443 and 7 more |
| Lot numbers | 401222RH, 401223RH, 401226RH, 401227RH, 401260RH, 401261RH, 401306RH, 401309RH, 401312RH, 401430RH, 401433RH, 401435RH, 401441RH, 401442RH, 401443RH, 401448RH, 401449RH, 401450RH, 401451RH, 401860RH, 401877RH, 401878RH, 401890RH, 401891RH, 401994RH, 402004RH, 402008RH, 402009RH, 402010RH, 402012RH, EP250203, EP250307, EP250317 |
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 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
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-1322-2026. 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.