CLASS I ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Reprocessed Inquiry Steerable Diagnostics Catheter recalled
Medline Industries is recalling Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac, distributed nationwide in the US. The recall was initiated on 31 Jul 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2612-2025
- FDA event ID
- 97496
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 31 Jul 2025
- FDA classified
- 26 Sep 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 31 Jul 2025 | Recall initiated by company | |
| 26 Sep 2025 | Classified by FDA | +57 days |
| 8 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Product as listed by the FDA
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Where it was distributed
Domestic US distribution nationwide. International distribution pending. No international distribution.
Questions about this recall
Why was it recalled?
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Which lots are affected?
Item Number/UDI-DI 81102RH 10197344133239; 81104RH 10197344133246; 81107RH 10197344133260; 81174RH 10197344133291; 81402RH 10197344133352; 81404RH 10197344133376; 81405RH 10197344133383; 81472RH 10197344133413; 81473RH 10197344133420; 81474RH 10197344133437; 81531RH 10197344133512; 81532RH 10197344133529; LOTS EP250212 EP250214
Where was it sold?
Domestic US distribution nationwide. International distribution pending. No international distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97496This product is part of a recall event; the main page for the event is Reprocessed Livewire Steerable Electrophysiology Catheter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Reprocessed Livewire Steerable Electrophysiology Catheter recalled | Medline Industries | Particulate Matter | Nationwide | |
| CLASS I | Reprocessed Webster CS Catheter 10 Electrodes recalled | Medline Industries | Particulate Matter | Nationwide | |
| CLASS I | Reprocessed Acuson AcuNav Ultrasound Catheter recalled | Medline Industries | Particulate Matter | Nationwide | |
| CLASS I | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac recalled | Medline Industries | Particulate Matter | Nationwide |
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