Getinge PVC Thoracic Catheters Recall Over Bacterial Endotoxin Testing (Aug 7, 2026)
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Atrium Medical Corporation is recalling 2,533 Getinge PVC Thoracic Catheters due to an out-of-specification bacterial endotoxin test result in a single lot.
FDA recall: what the record actually shows
This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.", distributed us nationwide distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Atrium Medical Corporation initiated a voluntary recall of certain Getinge PVC Thoracic Catheters after an out-of-specification result related to bacterial endotoxin testing was identified in a single lot.
Which Products Are Affected
The recall covers 2,533 units of Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case, distributed nationwide in the United States. Affected models and lots include:
- Model 8124 (24FR), UDI-DI 00650862132243, Lot ME244852
- Model 8128 (28FR), UDI-DI 00650862132281, Lots ME244854, ME244855
- Model 8132 (32FR), UDI-DI 00650862132328, Lots ME244565, ME244858, ME244859
- Model 8136 (36FR), UDI-DI 00650862132366, Lot ME244861 Recall number Z-3112-2026. Classification: Class II.
What You Should Do
Customers should follow instructions provided by Atrium Medical Corporation regarding the recalled devices.
Why This Matters
The Class II recall involves a potential issue with bacterial endotoxin levels in the affected catheters distributed across the United States.
Source
FDA recall Z-3112-2026
Original source: FDA Official Notice ↗
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