FDA Device recall Z-3111-2026
Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case
- FDA Device
- Class II
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class II recall of Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case by Atrium Medical, citing an Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3111-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-07 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
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);
Reason
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Identifiers
| code_info | 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UD…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Atrium Medical
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
FDA Device · Class II · 2024-10-16 · Atrium Medical - FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3111-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.