Reprocessed ultrasound catheters recalled over residual material particles inside
Medline is recalling 94 units because these lots of reprocessed catheters may contain small particles of residual material.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters, covering catalog numbers 10439072RH and 10439236RH, among the catalog numbers listed in the enforcement record are being recalled by Medline Industries, LP.
The record states these lots of reprocessed catheters may contain small particles of residual material. It states that 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. The record notes this is an expansion of recall Z-2610/2614-2025.
The record lists 94 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock and follow Medline's instructions.
The recalled product
- Product
- 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; Bios
- Manufacturer
- Medline Industries, LP
- Affected units
- 94
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808
- 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808
- 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- HighMedline IVS Blood Culture Kits Recalled for Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Blood Culture Kits Recalled Due to Potential Seal Defects
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Eye and Cataract Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Same hazard · residual material
See all →- CriticalReprocessed ViewFlex ICE catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- CriticalReprocessed electrophysiology catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- CriticalReprocessed Livewire catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- CriticalReprocessed Webster CS catheters recalled over residual material particles
FDA (Devices) · 2026-02-18
- CriticalReprocessed Inquiry catheters recalled over residual material particles inside
FDA (Devices) · 2026-02-18