Aligned Medical Angio Pack Recall: FDA Alerts on 10 cc Syringe Disconnection Hazard
Immediate action: U.S. healthcare facilities must quarantine Aligned Medical Solutions Angio Pack kits (codes AMS6908E & AMS6908F). A faulty 10 cc control syringe adapter can loosen or disconnect, creating a serious risk of blood loss, infection, or air embolism.
Key Recall Details at a Glance
- Manufacturer/Recall firm: Windstone Medical Packaging dba Aligned Medical Solutions
- FDA publish date: April 20, 2026
- Product category: Sterile medical convenience kits (Angio Packs)
- Primary hazard: Rotating adapter on 10 cc control syringe may unwind, causing leakage or complete line separation
- Distribution: Nationwide (USA) — Manufactured 10/18/2024 – 11/13/2025 | Distributed 10/28/2024 – 11/28/2025
Official Sources
Which Aligned Medical Angio Pack Lots Are Affected?
| Kit Name | Product Code | DI Number | Lot Numbers |
|---|---|---|---|
| Angio Pack | AMS6908E | B098AMS6908E0 | 214875 |
| Angio Pack | AMS6908F | B098AMS6908F0 | 215436, 225001, 226706, 234088 |
How to Confirm Your Kit Is Recalled
The Angio Pack label is inside the sterile barrier pouch. Match both the product code and lot number against the table above, or download high-resolution label images directly from Aligned Medical Solutions:
Download label images from Aligned Medical Solutions
Health Risks Linked to the Faulty 10 cc Control Syringe
The Medline Namic 10 cc control syringe (part # 80085007) packaged inside the Aligned Medical Angio Pack may unwind during use. Documented hazards include:
- Partial or complete loss of connection between syringe and manifold
- Clinician biohazard exposure
- Patient blood loss or infection
- Air entry that can cause a life-threatening air embolism
Medline has reported three inadvertent air injections and one clinician exposure event; no fatalities have been recorded.
Required Actions for Healthcare Facilities
- Quarantine all AMS6908E and AMS6908F packs immediately.
- Contact Aligned Medical Solutions’ Quality Department at 406-259-6387 for:
- Quarantine labeling guidance
- Replacement syringes, if necessary
- Before patient use, remove and destroy any Medline 10 cc syringe in the kit.
- Dispose of defective syringes per facility medical-waste protocols.
- Report adverse events to FDA MedWatch via the online form or by calling 1-800-332-1088.
Official Recall Images of Aligned Medical Angio Pack Labels
Aligned Medical Angio Pack Recall – Frequently Asked Questions
- Why did the FDA recall the Aligned Medical Angio Pack kits?
- The 10 cc control syringe’s rotating adapter can loosen, risking blood loss, infection, or air embolism, prompting the FDA-monitored recall.
- Which Aligned Medical Angio Pack lot numbers are impacted?
- Lot 214875 for product code AMS6908E and lots 215436, 225001, 226706, 234088 for product code AMS6908F are included.
- What should my facility do with recalled Aligned Medical Angio Packs?
- Quarantine the kits, follow Aligned Medical Solutions’ relabeling instructions, remove and destroy the 10 cc syringe at point of care, and request replacement syringes if required.
- Have any injuries been linked to the Aligned Medical Angio Pack recall?
- No injuries have been reported to Aligned Medical Solutions; however, Medline logged three inadvertent air injections and one clinician exposure involving the same syringe model.
- How can I obtain replacement syringes for the recalled Aligned Medical Angio Packs?
- Call Aligned Medical Solutions’ Quality Department at 406-259-6387 or email fieldcorrectiveaction@alignedmedicalsolutions.com to request replacements.
- Can my facility continue using the Aligned Medical Angio Pack if we replace the syringe?
- Yes. After removing and destroying the faulty 10 cc syringe, the remaining sterile components may be used per normal protocol, provided all other recall instructions are met.