Getinge PVC Thoracic Catheter — Class II medical device recall Z-3113-2026
Ongoing recall by Atrium Medical Corporation, reported 2026-09-16, distributed nationwide. An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
| Recall number | Z-3113-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2026-08-07 |
| Classified | 2026-09-04 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 256 |
| Reason classes | microbial contamination, sterility, specification failure |
| UPC / GTIN / UDI-DI | 00650862150285, 00650862150360 |
| Lot numbers | ME244850, ME244891 |
| Model numbers | 00650862150285, 00650862150360, ME244850, ME244891 |
Product
Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28FR(15028), 2. 36FR(15036);
Reason for recall
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3113-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.