Lower risk Medical device recall · FDA · Published August 7, 2026

Getinge Thoracic Catheter Recall: Bacterial Endotoxin Testing Issue

Getinge recalls specific PVC thoracic catheters due to bacterial endotoxin testing failures in one lot. Affected units have model numbers 8016-8036 with specific lot numbers. Consumers should contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3111-2026Medical device Getinge ›

Lower-risk recall

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

✎ GovInfoNow plain-language explainer

Atrium Medical Corporation recalls Getinge PVC thoracic catheters with model numbers 8016-8036 that failed bacterial endotoxin testing in one lot. This could pose a risk of infection if used improperly. Read more at govinfonow.com/recall/1009692-getinge-thoracic-catheter-recall-bacterial-endotoxin-testing-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/1009692-getinge-thoracic-catheter-recall-bacterial-endotoxin-testing-issue · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3111-2026

Cite this page

“Getinge Thoracic Catheter Recall: Bacterial Endotoxin Testing Issue.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/1009692-getinge-thoracic-catheter-recall-bacterial-endotoxin-testing-issue. Based on FDA recall #Z-3111-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3111-2026%22&limit=1).

The FDA announced on 2026-08-07 that Atrium Medical Corporation is recalling Getinge PVC Thoracic Catheters due to an out-of-specification result related to bacterial endotoxin testing, according to the FDA.

How to tell if you have it

Brand: Getinge
Product: Getinge PVC Thoracic Catheter, Soft PVC Straight
Model Number 8016 (Size 16FR), UDI-DI 00650862130164, Lot ME244878
Model Number 8024 (Size 24FR), UDI-DI 00650862130249, Lot ME244835
Model Number 8028 (Size 28FR), UDI-DI 00650862130287, Lots ME244682, ME244836, ME244837, ME244681
Model Number 8032 (Size 32FR), UDI-DI 00650862130324, Lot ME244840
Model Number 8036 (Size 36FR), UDI-DI 00650862130362, Lot ME244686

The hazard

The recall addresses an out-of-specification result related to bacterial endotoxin testing in a single lot of catheters, according to the FDA.

Context

GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since 2017-11-22. Other recent recalls include an iCast Stent recall for UDI label error (2024-09-09), an ADVANTA VXT Vascular Graft recall for slider separation risk (2024-05-03), and an Oasis Drain recall for shortened expiration date risk (2023-11-01). Other recent recalls of similar products include a Codman CerebroFlo EVD Catheter recall for endotoxin risk (2026-04-10), a Becton Dickinson Swan-Ganz Catheter recall for infection risk from leaking hub (2026-04-08), and Medline medical procedure kits recalled for potential endotoxin levels (2026-03-19).

How to tell if you have this one

Check for model numbers 8016 (16FR), 8024 (24FR), 8028 (28FR), 8032 (32FR), or 8036 (36FR) with specific lot numbers listed in the recall notice.

Brand
Getinge
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-3111-2026	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);; 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;	3618
Z-3112-2026	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);; 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;	2533
Z-3113-2026	Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);; 1. Model Number(Size): 15028(28FR); UDI-DI: 00650862150285; Lot Number: ME244891; 3. Model Number(Size): 15036(36FR); UDI-DI: 00650862150360; Lot Number: ME244850;	256

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to Atrium Medical Corporation for specific details about your catheter model and lot number.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Aug 7, 2026Firm started the recall
Sep 4, 2026FDA classified it Class II
Sep 16, 2026Published in FDA’s Enforcement Report
Sep 23, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Getinge recalls

Link to this recall

<a href="https://govinfonow.com/recall/1009692-getinge-thoracic-catheter-recall-bacterial-endotoxin-testing-issue">Getinge Thoracic Catheter Recall: Bacterial Endotoxin Testing Issue (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3111-2026 (August 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3111-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.