Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Trumpet, Needle Guide, Cat# TMS-200

FDA Recall Z-1460-2024 · Posted 2024-04-02

Recalling FirmTechnicality Inc.
Recall StatusOpen, Classified
Product CodeMDM
Date Initiated2024-01-31
Product Quantity20000 units

Reason for Recall

The Ring on the Trump Needle Guide can detach when excessive pressure is applied.

Firm Action

Technicality Medical Supplies, Inc. issued a Urgent Field Safety Notice to its sole consignee via email on 01/31/2024. The notice explained the problem with the device and requested the consignee quarantine any affected product in inventory and contact their customers.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of Illinois.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑