FDA announces more recalls due to risk of syringe breaking during treatment
Medline, an Illinois-based medical supplier that went public in December 2025, had to recall millions of Namic angiographic control syringes in early April due to a risk of the device breaking during use. The issue was linked to four series injuries, and the U.S. Food and Drug Administration (FDA) ruled it a Class I recall due to the severe risk.
It turns out, however, that that initial recall was just the beginning.
The FDA has now finalized more Class I recalls for procedure kits from Avid Medical, American Contract Systems and Medical Action Industries because they contain these Medline syringes. Many of these procedure kits are used to treat heart patients.
In addition, the agency has warned the public that procedure kits from Aligned Medical Solutions may also need to be recalled; the FDA is still reviewing that situation before making a final determination.
These recalls do not mean the procedure kits need to be destroyed or returned to the manufacturer. Instead, the FDA is asking companies to review their inventories and apply warning labels to any affected kits that say the Namic angiographic control syringes should be “removed and discarded from further use.”
Everything else in the kits can be used by clinicians as originally intended.
Medline's Namic Angiographic 12 mL Control Syringe with Rotator. Image courtesy of Medline.
More details about using these high-risk devices
These syringes are used in cardiac cath labs or interventional radiology suites for the intra-arterial or intravenous administration of radiographic contrast media.
In general, the affected devices should not be used to treat any patients. However, if a healthcare provider has no other options and must use one of these syringes, Medline and the FDA have emphasized the importance of using “extreme caution and vigilance” to avoid any complications.
An Urgent Medical Device Recall notice has been sent to all customers with additional details.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.