Class II

Medical Device Recall: Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);

Atrium Medical Corporation · August 7, 2026

Reason for Recall

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

2533

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3112-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.