Class II

Medical Device Recall: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);

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

3618

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3111-2026

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.

Atrium Medical Corporation Medical Device Recall: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036); | SafeCheck