Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Spiggle & Theis Injection Needles Recalled for Risk of Allergic Reactions

Agency Publication Date: August 15, 2025
Share:
Sign in to monitor this recall

Summary

Spiggle & Theis Mt Gmbh is recalling specific bayonet-style Luer-Lock injection needles because they were found to have elevated cytotoxicity levels. The recall includes Model 50-353-23 and Model 50-345-23, which are non-sterile medical instruments. Healthcare providers and facilities should stop using these needles immediately and contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

The elevated cytotoxicity values mean the materials used in the needles may be toxic to cells. Using these needles during a medical procedure may cause an intolerance or allergic reaction in the patient.

What You Should Do

  1. This recall affects Spiggle & Theis bayonet Luer-Lock injection needles, specifically Model 50-353-23 (Lot 2241239) and Model 50-345-23 (Lots 2230438 and 2240251).
  2. Identify the affected products by checking the label for Model No 50-353-23 (UDI-DI 04250381858806) or Model No 50-345-23 (UDI-DI 04250381858813).
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Injection needle, bayonet, Luer-Lock, Model no. 50-353-23
Variants: working length 25 cm, total length 31cm, nonsterile
Model / REF:
50-353-23
Lot Numbers:
(0)2241239
UDI:
04250381858806

Affected product show elevated cytotoxicity values.

Product: Injection needle, bayonet, Luer-Lock, Model no. 50-345-23
Variants: working length 24 cm, total length 31 cm, non-sterile
Model / REF:
50-345-23
Lot Numbers:
2230438
2240251
UDI:
04250381858813

Affected product show elevated cytotoxicity values.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97229
Status: Active
Manufacturer: Spiggle & Theis Mt Gmbh
Sold By: Medical supply distributors
Manufactured In: Germany
Distributed To: California, Connecticut, Missouri, Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.