Z-1723-2026Class I
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-02-27 / Open, Classified
Medline Industries, LP began a recall of Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR... on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1723-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596
- Product code
- FTN Plastic Surgery And Accessories Kit
- Reason for recall
- 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.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries, LP issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk. Required Action: Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 60 kits
- Distribution
- Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
- Product codes and lots
- Medline Kit SKU # DYNJ86596, UDI/DI each 10195327656119, UDI/DI case 40195327656110, Lot Numbers: 24FMI029, 24DMK138.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1712-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1713-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1714-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1715-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1716-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1717-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1718-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1719-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1720-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1721-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1722-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1723-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1724-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1725-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1726-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1727-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1728-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1729-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1730-2026 | Class I | Ongoing | Voluntary: Firm initiated |
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