Hollister has recalled 2,526,120 intermittent catheters distributed nationwide in the United States, under recall number Z-2998-2026. The firm began the action on 2026-07-14 and FDA posted the record on 2026-08-21. The devices are cleared under K211436 and sit in product code GBM. The recalling site is in Ballina, Ireland.
The stated reason is that select lots “may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding”. The firm's field safety notice asks consignees to inspect each catheter for a protrusion about 2 cm from the funnel, and not to use one that has it.
The root cause on the record is process control, which is the cause firms name on more recalls than any other. MDM's read of five years of that field is here.
FDA lists the recall as open and classified, which means the agency has assigned it a class and the action has not been terminated. The figures here are from FDA's device recall dataset, bulk export dated 2026-09-04.