FDA-Device2026-09-16Class IIPROCESSING DEFECT
Getinge PVC Thoracic Catheter recalled for bacterial endotoxin contamination
What this means
Atrium Medical Corporation (Getinge) identified an Out of Specification result for bacterial endotoxin testing in specific lots of PVC Thoracic Catheters. Two lots—one 28FR model and one 36FR model—were affected. The contamination was found during quality testing.
- Check if you have a Getinge PVC Thoracic Catheter with lot number ME244891 (28FR model 15028) or ME244850 (36FR model 15036)
- Do not use affected catheters
- Contact your healthcare provider or hospital if the catheter was already used
- Report the lot number to Atrium Medical Corporation or your medical device distributor
The agency's original wording
Hazard
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
256
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3113-2026More Atrium Medical recalls
- FDA-Device2026-09-16Getinge PVC Thoracic Catheters recalled for bacterial endotoxin contamination
- FDA-Device2026-09-16Getinge PVC Thoracic Catheter recalled for bacterial endotoxin contamination
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