# FDA recall Z-3111-2026

> **Atrium Medical Corporation** · Class II · device recall initiated 2026-08-07.

## 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 for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3111-2026
- **Recalling firm:** Atrium Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-07
- **Report date:** 2026-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Merrimack, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3111-2026

## Citation

> MORVS. FDA recall Z-3111-2026. Retrieved 2026-10-14 from https://api.morvs.ai/recall/Z-3111-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*