Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S

FDA device recall Z-2066-2026 · posted 2026-05-08 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

Action taken

Firm began notifying consignees via email on April 2, 2026. Notice was titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to check inventory and quarantine affected products. Firm instructed consignees to over-label affected products with a sticker which states that at the time the kit is opened, the affected Medline syringe should be identified and set aside, and that the affected syringe should be rendered unusable and disposed of. Firm will provide labels for any kits that need to be identified.

Root cause

Device Design

Status

Open, Classified

Product code

LRO

Quantity affected

150 kits (US only)

Distribution

US Nationwide distribution in the state of Arizona.

Date initiated

2026-04-02

Date posted

2026-05-08

Location

Billings, MT