Particulate found inside an intravenous fluid — 95,412 units nationwide (B. Braun)

1A Class I recall of Lactated Ringer's

The U.S. FDA classified B. Braun Medical's recall of Lactated Ringer's injection as Class I (recall D-0540-2026, reported May 13, 2026, status ongoing, firm-initiated).

2The affected product and the reason

The affected product is Lactated Ringer's Injection USP (1000 mL container, Rx only, NDC 0264-7750-07, manufactured by B. Braun Medical, Bethlehem, PA). The recall reason is the presence of particulate matter. The recall was initiated April 28, 2026, affecting about 95,412 units, distributed U.S. nationwide.

3Why particulates in IV fluid matter

Lactated Ringer's is a basic intravenous (IV) fluid widely used for dehydration and volume replacement. Because it is administered directly into the body, particulate in the solution can cause serious harm such as vascular occlusion (embolism) or inflammation — the basis for the most serious Class I classification.

4The units of quantity do not line up

Sorting the 1,408 FDA recall records this site holds as of 2026-09-01 by the unit written in the quantity field, the largest group is units at 482, followed by kits at 152, cases at 90, bottles at 86, bags at 37 and vials at 32.

The same figure of 95,412 means something entirely different as bags than as cases. Because the units do not line up, the quantity fields cannot be summed across records to compare scale. Here 95,412 counts 1000 mL containers.