Quick Facts at a Glance
- Recall Date
- July 31, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- 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 electrophysiology catheter
- Model numbers
- BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, BD710FJ282RRH, LOTS EP241216, EP241218, EP241226, EP241231 +3 more
- 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
These catheters are used in electrophysiology mapping and ultrasound imaging for cardiac procedures. They are reprocessed devices intended for patient-contact during mapping.
Why This Is Dangerous
Residual particulates on patient-contacting surfaces pose infection or inflammatory risks. Dislodged particulates can cause granulomatous reactions or thrombi, leading to embolism.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Clinical risk exists during procedures using these catheters. No injuries are reported in the recall to date, but the potential for serious adverse events could result in extended hospital stays or additional surgeries if particulates cause embolic complications.
Practical Guidance
How to identify if yours is affected
- Check item numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
- Compare packaging and labeling to recall notice
Where to find product info
Lots and item numbers appear on device labeling and accompanying documentation provided with the lot
What timeline to expect
Remedy timing is determined by Medline. Recalls of this type typically resolve within weeks to months following notice.
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- Consult healthcare provider for alternatives and documentation guidance
How to prevent similar issues
- When purchasing reprocessed medical devices, verify sterilization and lot control
- Follow manufacturer and FDA recall communications
- Ask suppliers for COA or sterilization verification
Documentation advice
Keep recall letter, item numbers, lot numbers, and all communications with healthcare providers for records
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Product Details
Medline Industries BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, BD710FJ282RRH reprocessed catheter lots. Domestic US distribution nationwide. International distribution pending. Quantity 7913 es. No international distribution.
Reported Incidents
No injuries or incidents have been reported. This section reflects the information provided in the recall notice.
Key Facts
- Total units recalled: 7,913 es
- Hazard level: HIGH
- Item numbers: BD710DF282CRH, BD710DF282RRH, BD710FJ282CRH, BD710FJ282RRH
- Distribution: Domestic US nationwide
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Safety Guide
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