FDA (Devices) recall action 94537
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling 25.2 million Luer Lock disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity. The inaccuracy may pose a risk to patient health.
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.