Recall Z-2066-2026 ยท LRO General Surgery Tray
Windstone Medical Packaging, Inc.
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
| Date | May 8, 2026 (initiated Apr 2, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 150 kits (US only) |
| Distribution | US Nationwide distribution in the state of Arizona. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.