Cardinal Health revised its product correction for more than 27 million syringes on Feb 2, and the FDA upgraded the notice to a Class I recall — the most serious type.
Because of a change in manufacturing and rebranding, the syringes have different dimensions and were made by a new contract manufacturer.
"The dimensional changes made to the Cardinal Health Monoject syringes, when used with syringe pumps, PCA pumps or enteral syringe pumps, may result in recognition, compatibility, and pump performance issues, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding," the FDA said.
The latest update reports there have been zero deaths reported, but it does not mention any other adverse events.
In late 2023, the FDA opened an investigation into China-made plastic syringes because of reports of incompatibilities, with products breaking and leaking.