FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.
- Recall number
- Z-1704-2011
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555; Manufactured by Stryker Endoscopy Puerto Rico.
- Status
- Terminated
- Initiated
- 2010-02-25
- Posted
- 2011-03-17
- Terminated
- 2011-03-18
- Reason
- The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
- Root cause
- Device Design
- Action
- All Sales reps were notified of the recall on February 25, 2010. Urgent Device Removal advisory notices were also sent to all consignees.Device Removal letters identified the specific part numbers and lot numbers involved. Letters also list the potential risk to patients as a result of the issue. Customers are asked to inspect their inventory for part and lot numbers and quarantine any affected product. If recalled product is found, customers are to contact Stryker Customer Service at 800-624-4422 and request an RMS to send back recalled units. New units will be provided at no charge. The acknowledgement form is to be completed and returned. Questions or concerns should be directed to 408-754-2000 or e-mail at eprobe@stryker.com.
- Quantity
- 31, 014 units
- Distribution
- Worldwide Distribution -- US, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury.
- Lot, serial or model codes
- 09158FE2, 09161FE2, 09164FE2, 09170FE2, 09174FE2, 09176FE2, 09219FE2, 09226FE2, 09233FE2, 09339FE2, 09264FE2, 09204FE2, 09205FE2, 09210FE2, 09211FE2, 09217FE2, 09120FE2, 09170FE2, 09181FE2, 09181FE2P, 09175FE2, 09209FE2, and 09167FE2.
- 510(k) numbers
- ["K052141"]
- PMA numbers
- not on file
- Product code
- GEI
- 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