FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
- Recall number
- Z-0652-2009
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
- Status
- Terminated
- Initiated
- 2008-10-01
- Posted
- 2009-01-21
- Terminated
- 2010-12-16
- Reason
- Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.
- Root cause
- Process control
- Action
- Stryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.
- Quantity
- 1440 devices
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number: 08E0451
- 510(k) numbers
- ["K944210"]
- PMA numbers
- not on file
- Product code
- HRX
- 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