FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
- Recall number
- Z-0972-2009
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
- Status
- Terminated
- Initiated
- 2008-06-20
- Posted
- 2009-02-09
- Terminated
- 2009-06-22
- Reason
- The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
- Root cause
- Process control
- Action
- On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.
- Quantity
- 2463 units
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- 08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2
- 510(k) numbers
- ["K041810"]
- 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