FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
- Recall number
- Z-0310-05
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- Brand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308 [All products are packaged one unit per box.]
- Status
- Terminated
- Initiated
- 2004-10-29
- Posted
- 2004-12-15
- Terminated
- 2012-07-07
- Reason
- The firm received six reports of tubes with wires 'out of channel' two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.
- Root cause
- Other
- Action
- not on file
- Quantity
- 22569 EMG Tubes
- Distribution
- Distributed nationwide and worldwide. to countries in the five continents with the highest populations.
- Lot, serial or model codes
- Product Code: 77 ETN Lot Numbers: 32423300 through 35505400, and 35542200, 35542300, 35542400, 35542500, 35542600, 35543400, 35597200, 35602100, 35633400, 35633600, 35638200, 35638400
- 510(k) numbers
- ["K925640"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- 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