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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.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Technicality Inc.: Trumpet Needle Guide Recalled for Potential Ring Detachment and Injury Risk

Agency Publication Date: April 2, 2024
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Summary

Technicality Inc. is recalling approximately 20,000 units of the Trumpet Needle Guide (Model TMS-200) because the ring component can detach from the guide when excessive pressure is applied during use. This voluntary recall affects lot numbers 22190 and 22497 of the surgical device. If the ring detaches during a medical procedure, it could lead to procedural delays or unintended contact with the patient. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact the manufacturer for further guidance.

Risk

The ring on the needle guide may break away from the main assembly under pressure, which could cause the device to fail during a procedure or leave a detached component in the surgical field. This poses a risk of injury to the patient or a delay in critical medical care.

What You Should Do

  1. Check your medical supplies and inventory for the Trumpet Needle Guide with Catalog Number TMS-200.
  2. Verify if your product matches the affected Lot Numbers 22190 or 22497.
  3. Immediately set aside any affected units to ensure they are not used in medical procedures.
  4. Contact your healthcare provider or Technicality Inc. at their Addison, Illinois facility located at 661 S Addison Rd, Addison, IL 60101-4648 for further instructions and potential refund or replacement information.
  5. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer or provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Trumpet, Needle Guide, Cat# TMS-200
Model / REF:
TMS-200
Lot Numbers:
22190
22497

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94135
Status: Active
Manufacturer: Technicality Inc.
Sold By: Technicality Inc.
Manufactured In: United States
Units Affected: 20000 units
Distributed To: Illinois

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.