Medline Industries, LP: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

Recall number

Z-1730-2026

Recalling firm

Medline Industries, LP

Product

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

Status

Open, Classified

Initiated

2026-02-27

Posted

2026-04-07

Terminated

not on file

Reason

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.

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 recalls@medline.com.

Quantity

82 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).

Lot, serial or model codes

1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJH

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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