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
- Reprocessed Livewire Steerable Electrophysiology Catheter
- Model numbers
- 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH +12 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
Why This Is Dangerous
Residual particulates on patient-contacting surfaces can cause inflammation or infection. If particulates enter the bloodstream or heart, they may trigger granulomatous reactions, thrombus formation, or embolic events.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals may need to stop using the affected devices and replace them, potentially delaying procedures and increasing costs for facilities.
Practical Guidance
How to identify if yours is affected
- 1. List all device item numbers in your facility inventory.
- 2. Check packaging and labeling for the listed item numbers.
- 3. Cross-check against hospital procurement records and supplier catalogs.
Where to find product info
Refer to the recall notice and the FDA enforcement page linked therein for UDI and lot information.
What timeline to expect
Refunds or replacements typically take 4-8 weeks to process.
If the manufacturer is unresponsive
- Document all communications with Medline.
- Escalate to hospital risk management if supplier does not respond within 2-4 weeks.
How to prevent similar issues
- Avoid reprocessed EP catheters if possible; use single-use, sterile-discard catheters.
- Verify supplier recalls before device acceptance.
- Ensure robust traceability for all lot/UDI codes.
Documentation advice
Keep recall notice, purchase records, packing slips, and all correspondence with Medline as part of your risk management file.
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Product Details
Item numbers affected: 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH, 401904RH, 401905RH, 401908RH, 401914RH, 401915RH, 401918RH, 401932RH, 401933RH, 401934RH, 401938RH, 401939RH, 401940RH. Where sold: Domestic US distribution nationwide to healthcare facilities. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 20 item numbers affected
- Class I recall; Hazard Level HIGH
- Domestic US nationwide distribution; international distribution pending
- Manufacturer: Medline Industries, LP
- Remedy: Stop use and follow recall instructions
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Safety Guide
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