Quick Facts at a Glance
- Recall Date
- July 31, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Electrophysiology Catheters
- Model numbers
- 81102RH, 81104RH, 81107RH, 81174RH, 81402RH, 81404RH, 81405RH, 81472RH +6 more
- Sold at
- Multiple Retailers
- 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
The Inquiry Steerable Diagnostics Catheter is used for electrogram recording and cardiac stimulation during electrophysiologic studies. Medical professionals typically use this device to assess heart conditions and abnormalities, ensuring safe and effective healthcare delivery.
Why This Is Dangerous
Residual particulates on the catheter's patient-contacting surfaces can cause inflammatory reactions if they come into contact with tissues or fluids. Dislodged particles may enter the bloodstream, leading to severe complications such as embolism.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The high hazard level indicates a significant safety concern, warranting immediate action for those who have used the device. Consumers may face health risks that require careful monitoring and professional follow-up.
Practical Guidance
How to identify if yours is affected
- Check the item number on your catheter against the recall list.
- Verify if your medical provider has been notified of this recall.
- If unsure, consult with your healthcare provider to confirm device safety.
Where to find product info
Look for the item number printed on the packaging or the catheter itself. It is often located near the connector.
What timeline to expect
Expect a timeline of 4-6 weeks for processing any return or refund requests.
If the manufacturer is unresponsive
- Follow up with the manufacturer through their customer service line.
- Consider reaching out your healthcare provider for further assistance.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Research and verify medical devices before use, especially those that have been reprocessed.
- Stay updated on recalls to ensure safety compliance.
- Always consult healthcare providers regarding the safety of medical devices.
Documentation advice
Keep records of communications regarding the recall, including dates and details of any conversations with Medline or your healthcare provider.
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Product Details
- Medline Item Numbers: 81102RH, 81104RH, 81107RH, 81174RH, 81402RH, 81404RH, 81405RH, 81472RH, 81473RH, 81474RH, 81531RH, 81532RH - Recall Date: July 31, 2025 - Report Date: October 8, 2025 - Quantity: 7,913 units distributed nationwide
Reported Incidents
No incidents or injuries have been reported.
Key Facts
- 7,913 reprocessed catheters recalled
- Potential risk of inflammatory response or systemic infection
- Hazard classification: Class I
- Devices distributed nationwide in the US
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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