CLASS I ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Reprocessed Biosense Webster Soundstar eco Diagnostic recalled
Medline Industries is recalling Reprocessed Biosense Webster Soundstar eco Diagnostic Ultrasound Catheters: Biosense, distributed nationwide in the US. The recall was initiated on 22 Dec 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-1324-2026
- FDA event ID
- 98277
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 22 Dec 2025
- FDA classified
- 6 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Heart & Vascular Devices
Timeline
| 22 Dec 2025 | Recall initiated by company | |
| 6 Feb 2026 | Classified by FDA | +46 days |
| 18 Feb 2026 | 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
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
Product as listed by the FDA
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH
Where it was distributed
Distribution US nationwide.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
Where was it sold?
Distribution US nationwide.
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
6 other products · FDA event 98277This product is part of a recall event; the main page for the event is Reprocessed Abbott Inquiry Steerable Diagnostic Catheters recalled.
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Other Heart & Vascular Devices recalls
All 6,268| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |