Recall Z-3111-2026— Atrium Medical Corporation

Name: FDA recall Z-3111-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2026-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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);. Reason: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-08-07
Firm location: Merrimack, NH, United States

Product description

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);

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.