Sterilmed recalls ACUSON catheters that may be reprocessed beyond safe limits, risking infection or vascular injury. Affected units have specific model numbers and lot codes.
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
Sterilmed is recalling ACUSON diagnostic ultrasound catheters that were reprocessed beyond validated cycles. This could lead to infection, vascular injury, or embolism if the catheter is used.
The catheters were reprocessed beyond the manufacturer's validated cycle limits. This can compromise sterility or mechanical integrity, potentially causing infections, vascular damage, or blood clots.
Healthcare professionals using the ACUSON catheters for diagnostic ultrasound are most at risk. Patients receiving these catheters could face serious complications.
Check for model number ACU10135910 and lot codes like 10888551004725. The catheters are labeled as 'ACUSON CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM'.
Immediately stop using the recalled ACUSON catheters as they may cause infection or vascular injury.
The catheters were reprocessed beyond validated cycles, which can compromise sterility or mechanical integrity and lead to infection, vascular injury, or embolism.
The affected model number is ACU10135910 with specific lot codes listed in the recall notice.
Check for the model number ACU10135910 and lot codes such as 10888551004725 on the catheter label.
We’ve drafted a message you can send Sterilmed to request your refund or repair — edit it as you like.
Subject: Recall Z-0573-2026 — Sterilmed Sterilmed Hello, I own a Sterilmed that is covered by recall Z-0573-2026 from Sterilmed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
