FDAFDA recall Z-3112-2026 · Sep 16, 2026
Atrium Medical Corporation: Getinge PVC Thoracic Catheter recall
Recall found
Product
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);
Reason for recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861;
- Quantity
- 2533
- Distribution
- US Nationwide distribution.
- Recalling firm
- Atrium Medical Corporation, Merrimack, NH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-07
Source: openFDA enforcement record Z-3112-2026 · search recall number Z-3112-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.