FDA recall Z-3111-2026

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

Status

Ongoing

Initiation date

2026-08-07

Report date

2026-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Merrimack, NH, United States

Primary source

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