FDA Medical Device Recalls (openFDA)
Technicality Inc.: Trumpet, Needle Guide, Cat# TMS-200
- Recall number
- Z-1460-2024
- Recalling firm
- Technicality Inc.
- Product
- Trumpet, Needle Guide, Cat# TMS-200
- Status
- Open, Classified
- Initiated
- 2024-01-31
- Posted
- 2024-04-02
- Terminated
- not on file
- Reason
- The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
- 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
- 20000 units
- Distribution
- US Nationwide distribution in the state of Illinois.
- Lot, serial or model codes
- Lot Numbers: 22190 & 22497
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1450901
- Firm city
- Addison
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28