FDA Medical devices recall ·
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case recall
- Recall number
- Z-3112-2026
- Date
- (initiated August 7, 2026)
- Company / brand
- Atrium Medical Corporation
40 Continental Blvd, Merrimack, NH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2533
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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);
Why was it recalled?
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3112-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.