FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
- Recall number
- Z-0279-06
- Recalling firm
- Stryker Endoscopy
- Product
- StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
- Status
- Terminated
- Initiated
- 2005-11-18
- Posted
- 2005-12-14
- Terminated
- 2006-11-02
- Reason
- Devices for which sterility may be compromised as evidenced by a crack in the package.
- Root cause
- Other
- Action
- On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
- Quantity
- 48405 boxes, 6 units per box
- Distribution
- The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
- Lot, serial or model codes
- Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
- 510(k) numbers
- ["K042454"]
- PMA numbers
- not on file
- Product code
- GCX
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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