FDA Medical Device Recalls (openFDA)
Stryker GmbH: Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
- Recall number
- Z-1849-2019
- Recalling firm
- Stryker GmbH
- Product
- Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1
- Status
- Terminated
- Initiated
- 2019-04-30
- Posted
- not on file
- Terminated
- 2020-09-18
- Reason
- The seal integrity of the sterile bag containing the kits may be compromised.
- Root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Recall notification letters dated 4/30/19 were sent to customers.
- Quantity
- 1600
- Distribution
- The products were distributed US nationwide.
- Lot, serial or model codes
- Lot #s 01404, 01478
- 510(k) numbers
- ["K922391"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
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