FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
- Recall number
- Z-1177-06
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
- Status
- Terminated
- Initiated
- 2006-06-02
- Posted
- 2006-06-27
- Terminated
- 2006-11-20
- Reason
- Device for which sterility may be compromised as evidenced by a loss of package integrity.
- Root cause
- Packaging process control
- Action
- On 6/2/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Lots 04051142--06121FE2, 04051142--06123FE2
- 510(k) numbers
- ["K943508"]
- PMA numbers
- not on file
- Product code
- HET
- 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