The Recall Desk
HighFDA (Devices)·Z-1460-2024·Announced 2024-04-10

Trumpet Needle Guide Ring May Detach Under Excessive Pressure

Technicality Inc. is recalling Trumpet Needle Guides (Cat# TMS-200) because the ring can detach when excessive pressure is applied. Approximately 20,000 units distributed nationwide in Illinois are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a potential risk-of-harm from component detachment, but no reported injuries or illnesses in the source. Per the rubric, risk-of-harm products without reported injury fall under the High (3) category.

Plain-English summary

Technicality Inc. is recalling the Trumpet Needle Guide (Cat# TMS-200). Approximately 20,000 units are subject to this Class II recall.

The ring on the needle guide can detach when excessive pressure is applied.

The recalled units were distributed nationwide in the state of Illinois. Affected lot numbers are 22190 and 22497.

The recalled product

Product
Trumpet, Needle Guide, Cat# TMS-200
Manufacturer
Technicality Inc.
Category
Medical Device — Needle Guide
Hazard
  • component-detachment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 22190 & 22497

Distribution

Distributed nationwide across the United States.

Related recalls

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