FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
- Recall number
- Z-2401-2021
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
- Status
- Terminated
- Initiated
- 2021-08-04
- Posted
- not on file
- Terminated
- 2025-03-11
- Reason
- The incorrect device is contained in the package.
- Root cause
- Employee error
- Action
- The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.
- Quantity
- 1,590 units
- Distribution
- International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
- Lot, serial or model codes
- Lot 4015424
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGK
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- 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