Atrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
Atrium Medical is recalling specific lots of Getinge PVC Thoracic Catheters because one lot failed bacterial endotoxin testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a potential adverse health consequence rather than a permanent one.
Plain-English summary
Atrium Medical Corporation is recalling 2,533 units of Getinge PVC Thoracic Catheters, Soft PVC Right Angle, in sizes 24FR, 28FR, 32FR, and 36FR. The recall is limited to specific lots identified by model numbers 8124, 8128, 8132, and 8136, with lot numbers including ME244852, ME244854, ME244855, ME244565, ME244858, ME244859, and ME244861.
The recall was initiated after an out-of-specification result was found in bacterial endotoxin testing for a single lot of catheters. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed nationwide in the United States. Healthcare facilities and consumers should check their inventory for the specific model and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- 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);
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 2,533
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft devices recalled due to slider component separation
FDA (Devices) · 2024-06-12
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · bacterial endotoxin
See all →- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
FDA (Devices) · 2025-04-02
- HighShoulder implant recalled due to excessive bacterial endotoxin
FDA (Devices) · 2024-09-25
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22