FDA recall, , Moderate risk
Getinge PVC Thoracic Catheter
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Summary by Recall Canary from the FDA notice
What happened
Atrium Medical Corporation of Merrimack, New Hampshire, recalled Getinge PVC Thoracic Catheters nationwide due to an Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. The recall, which began August 7, 2026, was added to the FDA's Enforcement Report on September 4, 2026, and included in the FDA's weekly enforcement report on September 16, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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);
- UDI-DI
- 00650862132243
- 00650862132281
- 00650862132328
- 00650862132366
- Lot code
- ME244852
- ME244854
- ME244855
- ME244565
- ME244858
- ME244859
- ME244861
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);
- UDI-DI
- 00650862130164
- 00650862130249
- 00650862130287
- 00650862130324
- 00650862130362
- Lot code
- ME244878
- ME244835
- ME244682
- ME244836
- ME244837
- ME244681
- ME244840
- ME244686
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
- UDI-DI
- 00650862150285
- 00650862150360
- Lot code
- ME244891
- ME244850
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Atrium Medical CorporationMerrimack, New Hampshire
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99680
- Recall numbers
- Z-3111-2026 to Z-3113-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
