FDA Device recall Z-2331-2025
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile
- FDA Device
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile by Spiggle And Theis Mt, citing affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2331-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-27 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spiggle And Theis Mt |
| Distribution | US |
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
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2025%22
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