Z-0484-2008

SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico

Name: Z-0484-2008 SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
Creator: Stryker Endoscopy
Published: 2007-04-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2007-04-26 / Terminated

FDA source

Stryker Endoscopy began a recall of SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico on 2007-04-26. The reason FDA records is "Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0484-2008
Status: Terminated
Initiated: 2007-04-26
Posted: 2008-01-17
Terminated: 2008-01-16
Recalling firm: Stryker Corp.
Product: SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker Puerto Rico
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)
FDA root cause: Mixed-up of materials/components
Action: Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a recall.
Quantity in commerce: 6,037 units
Distribution: Worldwide Distribution: USA including states of AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and WV; INTERNATIONAL: Affiliated Stryker Distribution Companies: Sweden (for Scandinavia area), Australia, Canada, France, Germany, Greece, South Africa, Iberia, Italy, Mexico, Portugal, Switzerland (2 separate sites), and The UK
Product codes and lots: Lot Numbers: 06361AE2 06362AE2 07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2 07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and 07044AE2

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)