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 in specific lots of PVC thoracic catheters used in medical procedures. The affected catheters were distributed nationwide. No injuries have been reported to date.
- Check if your facility received catheters matching the affected lot numbers (ME244878, ME244835, ME244682, ME244836, ME244837, ME244681, ME244840, or ME244686)
- Do not use affected catheters; quarantine and return them to Getinge
- Contact Getinge or your medical device supplier for replacement stock
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
3618
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
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);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3111-2026More 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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