Z-1460-2024Class II

Trumpet, Needle Guide, Cat# TMS-200

Name: Z-1460-2024 Trumpet, Needle Guide, Cat# TMS-200
Creator: Technicality Inc.
Published: 2024-01-31
License: https://open.fda.gov/license/

Technicality Inc. / initiated 2024-01-31 / Open, Classified / root cause: manufacturing process

FDA source

Technicality Inc. began a recall of Trumpet, Needle Guide, Cat# TMS-200 on 2024-01-31. FDA classified it as Class II and gives the reason as "The Ring on the Trump Needle Guide can detach when excessive pressure is applied". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1460-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-31
Posted: 2024-04-02
Recalling firm: Technicality Inc.
Product: Trumpet, Needle Guide, Cat# TMS-200
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 20000 units
Distribution: US Nationwide distribution in the state of Illinois.
Product codes and lots: Lot Numbers: 22190 & 22497

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1460-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1460-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-02

Product code MDM

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)