Quick Facts at a Glance
- Recall Date
- July 31, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Ultrasound Catheter
- Model numbers
- 10135910RH (for GE Systems) 10197344026500, 10135936RH (for Siemens Systems) 10197344026517, LOTS EP241021 EP241114 EP241226 EP250213 EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 31, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
Reprocessed ACUSON AcuNav ultrasound catheters are used for intracardiac and great vessel visualization during interventional procedures. They provide imaging guidance.
Why This Is Dangerous
Residual particulates on patient-contacting surfaces may trigger inflammatory responses or infections. Particulates could dislodge and cause emboli.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to patients during procedures; immediate stop-use required; potential for serious embolic events and infection.
Practical Guidance
How to identify if yours is affected
- Confirm GE or Siemens compatibility per model numbers 10135910RH and 10135936RH.
- Verify item numbers 10135910RH and 10135936RH.
Where to find product info
FDA recall page Z-2614-2025 and Medline communications.
What timeline to expect
Recall notifications will specify steps for replacement or refund; processing times vary by manufacturer.
If the manufacturer is unresponsive
- Document all communications with Medline and healthcare providers.
- Escalate to FDA through MedWatch if necessary.
How to prevent similar issues
- Enhance supplier lot-traceability for reprocessed devices.
- Verify cleanliness and absence of particulates in reprocessed catheters before use in future purchases.
Documentation advice
Keep all recall notices, lot numbers, and healthcare communications as part of medical device incident records.
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Product Details
Brand: Medline Industries, LP. Product: Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization. Item numbers referencing use with GE and Siemens systems. Lots EP241021, EP241114, EP241226, EP250213; EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, EP250219. Quantity: 7913 eaches. Distribution: Domestic US nationwide. International distribution pending, none reported.
Reported Incidents
No explicit incident counts provided in the notice. The FDA enforcement report indicates a Class I recall with high hazard level.
Key Facts
- For GE and Siemens systems compatibility: 10135910RH 10197344026500; 10135936RH 10197344026517
- Active status as of 2025-10-08
- Distribution within the United States; international distribution pending
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Safety Guide
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