FDA-Device2026-09-16Class IIPROCESSING DEFECT
Getinge PVC Thoracic Catheters recalled for bacterial endotoxin contamination
What this means
Getinge PVC Thoracic Catheters in several sizes (24FR, 28FR, 32FR, and 36FR) failed bacterial endotoxin testing in specific lots. Endotoxins are substances from bacteria that can trigger immune reactions if present on medical devices.
- Check if your facility received affected lots: 24FR (ME244852), 28FR (ME244854 or ME244855), 32FR (ME244565, ME244858, or ME244859), or 36FR (ME244861).
- Do not use affected catheters; quarantine and return them to your distributor.
- Contact Getinge or your supplier for instructions on replacement or credit.
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
2533
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
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);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3112-2026More Atrium Medical recalls
- FDA-Device2026-09-16Getinge PVC Thoracic Catheter recalled for bacterial endotoxin contamination
- FDA-Device2026-09-16Getinge PVC Thoracic Catheter recalled for bacterial endotoxin contamination
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