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, PREGNANT
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
- Syringe and Angiographic Rotating Adaptor
- Model numbers
- Medline SKU # DYNJ80513B, UDI/DI each 10198459389375, UDI/DI case 40198459389376, Lot Numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993 +1 more
- 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
Medline NAMIC Angiographic Rotating Adaptor syringes are used in interventional procedures as part of surgical kits.
Why This Is Dangerous
Unwinding adaptor can create a loose connection or disconnection between syringe and manifold, potentially impacting function.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate action required. Medical devices with potential connection failure can affect sterile technique and procedure outcomes.
Practical Guidance
How to identify if yours is affected
- Find Medline SKU DYNJ80513B Special Procedure Tray kit.
- Check UDI/DI 10198459389375 for syringe and 40198459389376 for case.
- Review lot numbers 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283.
Where to find product info
FDA enforcement page Z-1720-2026 and Medline recall communications.
What timeline to expect
Refunds or replacements will follow Medline's recall process; timelines vary by case.
If the manufacturer is unresponsive
- Escalate to Medline customer service
- File a report with FDA if advised
- Consult healthcare provider for interim measures
How to prevent similar issues
- Verify adaptor connections before use in any procedure
- Follow Medline recall materials for disposition
- Monitor for updates from FDA/Medline on recall status
Documentation advice
Keep recall notice, order details, lot numbers, and any communications; document disposition and replacements.
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Product Details
Medline SKU # DYNJ80513B. Kit: SPECIAL PROCEDURE TRAY. UDI/DI numbers: 10198459389375 (syringe), 40198459389376 (case). Lot numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283. Quantity recalled: 762 units. Distribution: Worldwide including US, PR, CA, NL, AU, KR, LK, PK, JP, AE, SG, SK.
Reported Incidents
No injury counts are provided in the recall notice. The status is active with a HIGH hazard level.
Key Facts
- Special Procedure Tray kit with Medline SKU DYNJ80513B
- Syringe UDI/DI 10198459389375
- Case UDI/DI 40198459389376
- Worldwide distribution including US and PR; exports to CA, NL, AU, KR, LK, PK, JP, AE, SG, SK
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Safety Guide
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