FDA recall Z-2331-2025

Product

Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile

Reason for recall

Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.

Distribution

US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.

Key facts

Status

Ongoing

Initiation date

2025-06-27

Report date

2025-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dieburg, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2025