Atrium Medical Corporation recalls Getinge PVC Thoracic Catheter
- Recalling company
- Atrium Medical Corporation
- Product
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- 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
- 256
- Lot / codes
- 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;
- Company location
- Merrimack, NH
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3113-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3113-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.