Z-0972-2009

Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured...

Name: Z-0972-2009 Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured...
Creator: Stryker Endoscopy
Published: 2008-06-20
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-06-20 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico on 2008-06-20. The reason FDA records is "The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0972-2009
Status: Terminated
Initiated: 2008-06-20
Posted: 2009-02-09
Terminated: 2009-06-22
Recalling firm: Stryker Corp.
Product: Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 2463 units
Distribution: Worldwide Distribution.
Product codes and lots: 08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2

Product code GEI

K041810Class IISerfas Energy SystemStryker Endoscopy / cleared 2004-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)