Class I U.S. Food and Drug Administration

Aligned Medical Angio Pack Angio Packs recall: Risk of the syringe rotating adapter unwinding during use

Recall published 7 months ago

Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism.

Aligned Medical Angio Pack Medical devices — recalled medical devicesAligned Medical Angio Pack Medical devices — recalled medical devices (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: This product has been recalled because Medline has identified through post-market surveillance, risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2066-2026
Published
April 16, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Aligned Medical Angio Pack
Product type
Medical devices
Units affected
150 kits (US only)
Distribution
Nationwide
Lot / code info
Pack AMS6908E UDI-DI B098AMS6908E0 Lot 214875 Pack AMS6908F UDI-DI B098AMS6908F0 Lots 215436, 225001, 226706, 234088
Reports of harm
No injuries have been reported to Aligned Medical Solutions to date.

Products covered by this recall

Angio Packs (AMS6908E and AMS6908F)

What the company announced

On April 02, 2026, Aligned Medical Solutions, Billings, MT, initiated a nationwide recall of two convenience kits that contain the Medline Namic Angiographic Rotating Adapter(RA) 10CC Syringe. Associated kits are AMS6908E Angio Pack and AMS6908F Angio Pack.

Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Product labels can be viewed at the following link. Click Here.

Recalled products include:

  • Brand: Kit Name · Aligned Medical Solutions: Product Code · DI Number · Lot
  • Brand: Angio Pack · Aligned Medical Solutions: AMS6908E · B098AMS6908E0 · 214875
  • Brand: Angio Pack · Aligned Medical Solutions: AMS6908F · B098AMS6908F0 · 215436, 225001, 226706, 234088

These convenience kits contain the recalled Medline Namic Angiographic (RA) 10CC Syringe, Brand Name - Medline Medical Industries part # 80085007. This product has been recalled because Medline has identified through post-market surveillance, risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, and infection, as well as introduction of air into the line, which may result in air embolism – a condition that carries a serious injury or death. All units have the potential to exhibit this failure mode. There have been three instances reported to Medline of inadvertent air injection into the patient, and one instance of exposure to biohazard, none of these instances have resulted in death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=219145

Aligned Medical Solutions distributed these kits nationwide. Recalled Product(s) were manufactured from 10/18/2024 to 11/13/2025 and distributed from 10/28/24 to 11/28/2025

No injuries have been reported to Aligned Medical Solutions to date.

Customers who have affected product(s) should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement product if needed at 406-259-6387. Customers will be provided with a label that is to be placed on the packs containing the recalled Medline Namic Angiogrphic (RA) 10CC Syringe. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled syringe. At the time the kit is opened for use any MEDLINE 10cc Syringe should be removed and destroyed.

The recalled MEDLINE 10cc Control Syringe should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement syringes if requested.

Customers with questions may contact the company via telephone at 1-800-360-9428 between the hours of 8:00 am and 5:00 pm (Mountain Time). Customers may also contact the company via email at [email protected] .

Please contact Vicki Davis at [email protected] for replacement product or via telephone 406-259-6387 between the hours of 8:00 am and 5:00 pm (Mountain Time)..

Aligned Medical Solutions has notified the FDA of this action.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting via:

Complete and submit the report: Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 225001
  • 226706

Model or item number

On the rating label, the box or the instruction sheet.

  • 80085007
  • AMS6908E

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Aligned Medical Angio Pack — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Remedy named in the notice: Contact the Quality Department for further instructions on labeling and replacement product if needed at 406-259-6387.

Company contact: Windstone Medical Packaging dba Aligned Medical Solutions — Consumers: 1-800-360-9428, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Aligned Medical Angio Pack medical devices recalled?

Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism. This product has been recalled because Medline has identified through post-market surveillance, risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 225001, 226706; model number 80085007, AMS6908E. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: Contact the Quality Department for further instructions on labeling and replacement product if needed at 406-259-6387.

Where was the recalled product sold?

It was distributed nationwide.

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