Spiggle & Theis Mt Gmbh: Medical Device Recall in 2025 - (Recall #: Z-2331-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 27, 2025

Date Posted: August 27, 2025

Recall Number: Z-2331-2025

Event ID: 97229

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

Code Information:

1. Model No 50-353-23; UDI-DI 04250381858806; LOT (0)2241239 2. Model No 50-345-23; UDI-DI 04250381858813; LOT 2230438; LOT 2240251

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated