FDA Device recall Z-3112-2026
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 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 Right Angle, 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-3112-2026 |
| 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 Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
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): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UD…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; |
|---|
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 Straight, 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-3112-2026%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.