HIGHFDA DEVICE

Medline NAMIC Angiographic Adaptor Syringes Recalled in Class I Action for Rotation Unwinding Risk

Medline Industries, LP recalled 594 medical convenience kits worldwide, including NAMIC Angiographic Rotating Adaptor syringes, due to a potential unwinding of the syringe adaptor that can cause a loose connection or disconnection with the manifold.

Official notice
Medline Industries, LPHealth & Personal CareMedical DevicesMedline SKU # CDS780138KUDI/DI each 10198459205552UDI/DI case 40198459205553

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 27, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
February 27, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Unknown
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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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
NAMIC Angiographic Rotating Adaptor (RA) Control Syringes
Model numbers
Medline SKU # CDS780138K, UDI/DI each 10198459205552, UDI/DI case 40198459205553, Lot Number: 25EBR802, Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 25AMH487 +6 more
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    February 27, 2026

  2. Reported by FDA DEVICE

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. 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 control syringes are used in catheterization procedures to connect syringe to angiographic manifolds.

Why This Is Dangerous

Unwinding adaptor can lead to a loose or complete disconnection during use, potentially impacting sterile technique and procedural integrity.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Immediate action required for healthcare facilities using these kits to prevent potential disruption of sterile cardiovascular procedures.

Practical Guidance

How to identify if yours is affected

  1. Check if your kit includes NAMIC Angiographic RA control syringes within the listed Medline kits.
  2. Review SKUs: CDS780138K; DYNJ36478B; DYNJ910458; VASC1081C; VASC1510.
  3. Inspect for lot numbers: 25EBR802, 25AMH487, 24JMC622, 24EMD869, 24LLA039.

Where to find product info

Refer to the FDA recall page and Medline recall communications for exact lot and SKU data.

What timeline to expect

Refunds or replacements typically within 4-8 weeks after recall processing.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or seek assistance from the FDA recall office.
  • Document all communications with Medline and keep proof of recall notification.

How to prevent similar issues

  • Verify accessory compatibilities when sourcing replacement NAMIC RA components.
  • Implement a supplier recall readiness plan for surgical kits.
  • Training on kit assembly to ensure correct connections and checks before use.

Documentation advice

Retain recall notification, lot and SKU data, and correspondence records for future reference.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. Labeled as: 1) HEAD AND NECK CDS-LF, CDS780138K; 2) HEART CATH PACK-LF, DYNJ36478B; 3) HEART CATH PACK-LF, DYNJ36478B; 4) HEART CATH PACK-LF, DYNJ36478B; 5) THYROIDECTOMY, DYNJ910458; 6) LH 3 PORT W/O WASTEBAG, VASC1081C; 7) LHK, VASC1510; 8) LHK, VASC1510. Distribution: Worldwide including US, PR and international: CA, NL, AU, KR, LK, PK, JP, AE, SG, SK. Recall date: 2026-02-27. Report date: 2026-04-15. Status: Active.

Reported Incidents

No incidents or injuries are described in the provided data. The recall is classified as Class I, based on potential risk.

Key Facts

  • Class I recall
  • Syringe adaptor unwinding risk
  • Loose connection or disconnection with manifold
  • Global distribution including US and PR
  • SKU/UDI references: CDS780138K; DYNJ36478B; DYNJ910458; VASC1081C; VASC1510; Lot numbers 25EBR802, ¼

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTPETS
Injury Types
ELECTRICALLACERATIONOTHERFALL

Product Classification

Product Details

Model Numbers
Medline SKU # CDS780138K
UDI/DI each 10198459205552
UDI/DI case 40198459205553
Lot Number: 25EBR802
Medline SKU # DYNJ36478B
+9 more
Affected States
ALL
Report Date
April 15, 2026
Recall Status
ACTIVE

Related Recalls