Recall Z-2066-2026
Windstone Medical Packaging, Inc. · initiated April 2, 2026
Class I – dangerous or defective products that could cause serious health problems or death
Product
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Codes / lots: Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2066-2026
- Initiated
- April 2, 2026
- Posted by FDA
- May 8, 2026
- Product code
- LRO – General Surgery Tray
- Quantity
- 150 kits (US only)
- Distribution
- US Nationwide distribution in the state of Arizona.
- Recalling firm
- Windstone Medical Packaging, Inc., Billings, MT