Medline Industries Recalls Reprocessed Biosense Webster Ultrasound Catheters Due to Potential Contamination
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Medline Industries, LP has issued a Class I recall for 94 reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters due to the risk of residual material particles.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Medline Industries, LP has initiated a voluntary recall of specific lots of reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters. The FDA has classified this as a Class I recall, indicating a high level of severity. The recall was prompted by the discovery that these reprocessed devices may contain small particles of residual material. If used, these particles could trigger serious adverse health events.
Which Products Are Affected
The recall involves 94 units distributed nationwide across the United States. Affected products include:
- Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems: Model 10439072RH (UDI-DI 10197344157297)
- Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems: Model 10438577RH (UDI-DI 10197344157273)
- Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems: Model 10439011RH (UDI-DI 10197344157280)
- Additional Model: 10439236RH (UDI-DI 10197344157303)
Affected Lot Numbers: EP250724 and EP250808.
What You Should Do
Medline Industries notified affected customers via letter starting on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the affected lot numbers (EP250724 and EP250808). Any affected devices should be quarantined and handled according to the instructions provided in the firm's notification letter. For further information regarding returns or specific procedures, facilities should contact Medline Industries, LP directly.
Why This Matters
The presence of residual material in these catheters poses a significant health risk to patients. Potential complications include inflammatory responses, systemic infections, granulomatous reactions, or thrombus reactions. These conditions may lead to life-threatening events such as cerebral or pulmonary embolisms or deep vein thrombosis.
Source
Original source: FDA Official Notice ↗
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