Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter

Recalling company

Atrium Medical Corporation

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 7, 2026

Reported

Sep 16, 2026

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

3618

Lot / codes

1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;

Company location

Merrimack, NH

Recall type

Voluntary: Firm initiated

Recall number

Z-3111-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3111-2026 in the FDA Enforcement Report. Also see FDA recall press releases.