Quick Facts at a Glance
- Recall Date
- February 27, 2026
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Angiographic Rotating Adaptor (RA) Control Syringe
- Model numbers
- Medline SKU # DYNJ84472, UDI/DI each 10195327369286, UDI/DI case 40195327369287, Lot Numbers: 23LBN016, 23KBL255, 23HBL885, 23FBV799.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 27, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
NAMIC Angiographic Rotating Adaptor syringes are used in interventional cardiovascular procedures often with transcatheter aortic valve replacement (TAVR).
Why This Is Dangerous
A rotating adaptor that unwinds can create a loose connection or disconnect from the manifold, potentially impacting procedural integrity.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Immediate discontinuation required. Potential impact on cardiovascular procedures and patient safety.
Practical Guidance
How to identify if yours is affected
- Check Medline SKU DYNJ84472 in the TAVR PACK
- Inspect lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799
Where to find product info
FDA recall page linked in notice; Medline customer service
What timeline to expect
Refunds/replacements typically processed within weeks to months depending on provider response
If the manufacturer is unresponsive
- Escalate to FDA recall program
- File a complaint with your hospital risk management
How to prevent similar issues
- Verify adaptor integrity before use in procedures
- Follow Medline's official instructions for recall
- Maintain updated device inventory controls
Documentation advice
Keep recall notice, batch/lot numbers, and correspondence with Medline for records
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Product Details
Medline SKU DYNJ84472 within TAVR PACK. UDI/DI 10195327369286. Case UDI 40195327369287. Lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799. Quantity: 108 units. Sold worldwide including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK.
Reported Incidents
No specific injuries or incidents are described in the provided recall notice.
Key Facts
- High hazard class I
- Syringe rotating adaptor unwinding risk
- Worldwide distribution including US and PR
- Lot numbers 23LBN016, 23KBL255, 23HBL885, 23FBV799
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Safety Guide
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