Z-2331-2025Class II

Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm...

Name: Z-2331-2025 Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm...
Creator: Spiggle & Theis Mt Gmbh
Published: 2025-06-27
License: https://open.fda.gov/license/

Spiggle & Theis Medizintechnik GmbH / initiated 2025-06-27 / Open, Classified

FDA source

Spiggle & Theis Mt Gmbh began a recall of 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... on 2025-06-27. FDA classified it as Class II and gives the reason as "Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2331-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-27
Posted: 2025-08-15
Recalling firm: Spiggle & Theis Medizintechnik GmbH
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
Product code: GDM Needle, Aspiration And Injection, Reusable
Reason for recall: Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
FDA root cause: Under Investigation by firm
Action: On June 27, 2025, the firm notified customers through a letter titled "Urgent safety information Recall Injection Needle". Customers were asked to identify and quarantine any affected product in stock. Customer service will assist customers in returning product and the firm will issue a credit upon receipt of the affected product.
Distribution: US Nationwide distribution in the states of California, Connecticut, Missouri, and Ohio.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2331-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-15

Product code GDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)