# FDA recall Z-1322-2026

> **Medline Industries, LP** · Class I · device recall initiated 2025-12-22.

## 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

## Distribution

Distribution US nationwide.

## Key facts

- **Recall number:** Z-1322-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-22
- **Report date:** 2026-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2026

## Citation

> AI Analytics. FDA recall Z-1322-2026. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-1322-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*